MTS Trials - BreastCancerTrials.org

1

Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Advanced Breast Cancer

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A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

Purpose: To study the safety, effects (good and bad), and best dose of DF1001 when it is given alone or with pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that tests HER2 1+, 2+ or 3+ on the IHC (immunohistochemistry) tumor test and have not had more than three lines of chemotherapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 immunotherapy</li> </ul> You may also receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 is an experimental immunotherapy. </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04143711' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/msi-h/' target='_blank'>Merck Oncology Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dragonflytx.com/copy-of-about-us-1' target='_blank'>Dragonfly Therapeutics Information Page: DF1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6554437/' target='_blank'>Journal Article: Cancer Immunotherapy Based on Natural Killer Cells: Current Progress and New Opportunities</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/keytruda-approved-for-microsatellite-instability-high-and-mismatch-repair-deficient-cancers' target='_blank'>Cure Today: Keytruda Approved for Any Solid Tumor With a Specific Genetic Marker</a> </li></ul>

1

Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Advanced Breast Cancer

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A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

Nearest Location:
3 miles
University of California San Francisco
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04143711

Phase I-II

2

Alisertib Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

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A Phase 2 Study of Alisertib in Combination with Endocrine Therapy in Patients with HR+, HER2-negative Recurrent or Metastatic Breast Cancer (ALISCA-Breast1)

Purpose: To study the safety, best dose, and effects (good and bad) of alisertib, an experimental AURKA inhibitor, with standard of care hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received at least two hormone therapies including a CDK4/6 inhibitor with hormone therapy for advanced disease. You must not have received chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alisertib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alisertib is an experimental targeted therapy called an Aurora Kinase A (AURKA) inhibitor. Blocking AURKA may slow or stop cancer cells from growing.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06369285' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pumabiotechnology.com/clinical-trials/alisca_breast1.html' target='_blank'>Puma Biotechnology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/the-role-of-mtor-aurora-a-kinase-combination-therapy-requires-further-elucidation-in-solid-tumors' target='_blank'>OncLive: Alisertib for Advanced Solid Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/alisertib' target='_blank'>National Cancer Institute: Alisertib</a> </li></ul>

2

Alisertib Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

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A Phase 2 Study of Alisertib in Combination with Endocrine Therapy in Patients with HR+, HER2-negative Recurrent or Metastatic Breast Cancer (ALISCA-Breast1)

Nearest Location:
3 miles
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

Visits:
4 visits in 1 month, then 1 visit every month

ClinicalTrials.gov: NCT06369285

Phase II

3

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

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A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER)

Purpose: To study the anti-cancer activity and safety of giving the experimental anti-estrogen therapy giredestrant alone or with a CDK 4/6 inhibitor, an AKT inhibitor, a PI3K inhibitor, or chemotherapy.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer whose disease progressed while taking anti-hormone therapy with a CDK 4/6 inhibitor and who have not received chemotherapy for metastatic disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 6 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily, ongoing</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant is an experimental anti-estrogen therapy you take by mouth. It is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors. The only SERD currently approved to treat breast cancer is fulvestrant (Faslodex®). Faslodex is given by injection. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is also a CDK 4/6 inhibitor. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ipatasertib is an experimental type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT. </li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental type of targeted therapy called a PI3K inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Inavolisib may slow or stop cancer cells from growing by blocking this pathway. </li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04802759' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html' target='_blank'>Genentech Drug Information Page: Giredestrant (GDC-9545)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors (Abemaciclib & Ribociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Drug Information Page: Ipatasertib (AKT Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib (P13K Alpha Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/everolimus.aspx' target='_blank'>Chemocare: Everolimus (Afinitor)</a> </li></ul>

3

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

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A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER)

Nearest Location:
3 miles
University of California, San Francisco (UCSF)
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04802759

Phase I-II

4

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

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A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients with Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy (TRADE DXd)

Purpose: To test the safety and effectiveness of the sequence of 2 types of antibody drug conjugates (ADCs) to learn whether the treatment works for people with metastatic HER2 low breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low breast cancer. You must not have received more than 2 lines of chemotherapy or antibody drug conjugates for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li> </ul> followed by (after progression): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">MRI scans, every 2 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, every 3 weeks</li> </ul> followed by (after progression): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">MRI scans, every 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) and datopotamab deruxtecan (Dato-DXd) are antibody drug conjugates (ADCs).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd)'s antibody targets TROP2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">The US FDA has not approved datopotamab deruxtecan as a treatment for HER2-low metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">The US FDA has approved trastuzumab deruxtecan (Enhertu®) for previously treated HER2-low metastatic breast cancer, and for other uses.</li> <li class="seamTextUnorderedListItem">If you are randomized to a group and have already received the first drug, you may immediately skip to the second drug.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06533826' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

4

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

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A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients with Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy (TRADE DXd)

Nearest Location:
3 miles
University of San Francisco
San Francisco, CA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT06533826

Phase II

5

177Lu-FAP-2286 Radioactive Drug for Advanced Breast Cancer

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LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients With an Advanced Solid Tumor

Purpose: To study the safety, best dose, and effects (good and bad) of 177Lu-FAP-2286, an experimental radioactive drug.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 2 lines of therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">177Lu-FAP-2286, by IV, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">177Lu-FAP-2286 is an experimental radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">177Lu-FAP-2286 targets fibroblast activation protein (FAP) which is on cells near tumor cells and on some tumor cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04939610' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/177lu-fap-2286-yields-promising-preliminary-anti-tumor-activity-in-advanced-metastatic-solid-malignancies' target='_blank'>CancerNetwork: 177Lu-FAP-2286 Yields Promising Preliminary Anti-Tumor Activity in Advanced Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/radiopharmaceuticals-cancer-radiation-therapy#:~:text=Once%20a%20radiopharmaceutical%20has%20stuck,irreparably%20damaged%2C%20that%20cell%20dies' target='_blank'>National Cancer Institute: Radiopharmaceuticals</a> </li></ul>

5

177Lu-FAP-2286 Radioactive Drug for Advanced Breast Cancer

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LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients With an Advanced Solid Tumor

Nearest Location:
3 miles
UCSF Medical Center
San Francisco, CA

Visits:
1 visit every 2 weeks

ClinicalTrials.gov: NCT04939610

Phase I-II

6

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or ER Low Breast Cancer

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Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe)

Purpose: To look at the safety and effects (good and bad) of combining the immunotherapy drug avelumab (Bavencio®) with binimetinib, utomilumab, or PF-04518600.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) or ER Low (1%-10% ER) breast cancer who have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Binimetinib, by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-04518600, by IV, every 2 weeks </li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utomilumab, by IV, once a month</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bavencio is type of immunotherapy called a PD-L1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is targeted therapy that blocks MEK, which helps cancer cells grow. It is used to treat metastatic melanoma. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">PF-04518600 is an investigational immunotherapy that targets OX40, a protein found on immune cells that have interacted with cancer cells. </li> <li class="seamTextUnorderedListItem">Utomilumab is an investigational immunotherapy that targets the 4-1BB (CD-137) protein on certain immune cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03971409' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/avelumab' target='_blank'>NCI Drug Dictionary: Avelumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pf-04518600/' target='_blank'>Immuno-Oncology News: PF-04518600</a> </li><li class='seamTextUnorderedListItem'><a href='https://pfe-pfizercom-prod.s3.amazonaws.com/news/asco/Pfizer_IO_41BB_UtomilumabFactSheet.pdf' target='_blank'>Pfizer Oncology Information Page: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/binimetinib' target='_blank'>NCI Drug Dictionary: Binimetinib</a> </li></ul>

6

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or ER Low Breast Cancer

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Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe)

Nearest Location:
3 miles
University of California, San Francisco
San Francisco, CA

Visits:
1 visit every 2 weeks, ongoing

ClinicalTrials.gov: NCT03971409

Phase II

7

ETX-636 Targeted Therapy for Advanced HR+, HER2- Breast Cancer With PIK3CA Mutations

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A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ETX-636, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with PIK3CA mutations who have received at least 1 CDK4/6 inhibitor and hormone therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ETX-636, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ETX-636 is an experimental targeted therapy called a PI3K alpha inhibitor that blocks the growth of cancer cells with a PIK3CA mutation.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06993844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ensemtx.com/science/pipeline/' target='_blank'>Ensem Therapeutics: ETX-636 Drug Information Page</a> </li></ul>

7

ETX-636 Targeted Therapy for Advanced HR+, HER2- Breast Cancer With PIK3CA Mutations

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A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

Nearest Location:
3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

Visits:
At least 1 visit every month

ClinicalTrials.gov: NCT06993844

Phase I-II

8

ORIC-114 Targeted Therapy for Advanced HER2+ Breast Cancer

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An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ORIC-114, an experimental x, alone or with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and/or pemetrexed (Alimta®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114 is an experimental anti-HER2 targeted therapy and blocks EGFR and HER2. Blocking EGFR and HER2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and pemetrexed (Alimta®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05315700' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://oricpharma.com/pipeline/#oric114' target='_blank'>ORIC Pharmaceuticals: ORIC-114 Drug Information Page</a> </li></ul>

8

ORIC-114 Targeted Therapy for Advanced HER2+ Breast Cancer

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An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

Nearest Location:
5 miles
University of California, San Francisco
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05315700

Phase I-II

9

BNT327 with Chemotherapy for Advanced Triple Negative Breast Cancer

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A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer

Purpose: To study the safety, best dose, and effects (good and bad) of BNT327, an experimental anti-cancer therapy, with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR, HER2-) breast cancer who have received 0-1 lines of therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT327, by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT327 is an experimental anti-cancer therapy.</li> <li class="seamTextUnorderedListItem">You will receive at least one chemotherapy drug: either a taxol or combination of antimetabolite and alkylating agent.</li> <li class="seamTextUnorderedListItem">Taxol chemotherapy drugs include paclitaxel (Taxol®) and docetaxel (Taxotere®).</li> <li class="seamTextUnorderedListItem">Antimetabolite chemotherapy drugs include fluorouracil (5-FU) and methotrexate.</li> <li class="seamTextUnorderedListItem">Alkylating agent chemotherapy drugs include cyclophosphamide (Cytoxan®) and carboplatin (Paraplatin®).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06449222' target='_blank'>ClinicalTrials.gov</a> </li></ul>

9

BNT327 with Chemotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer

Nearest Location:
28 miles
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06449222

Phase II

10

eFT226 in Advanced Breast Cancer That Tests Positive for HER2, ERBB3, FGFR1, FGFR2, or KRAS Mutations

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A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Purpose: To evaluate the safety and effects (good and bad) of eFT226 (Zotatifin), an experimental targeted therapy that blocks eIF4A1.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that has been treated with standard therapies and tests positive for a mutation in HER2 (ERRB2), ERBB3, FGFR1, FGFR2, or KRAS. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">eFT226 (Zotatifin), by IV, weekly, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">eFT226 (Zotatifin) is an experimental targeted therapy that blocks eIF4A1. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of solid tumors that have these mutations.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2 (ERBB2), ERBB3, FGFR1, FGFR2, or KRAS</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04092673' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2019/11/05/1941103/0/en/eFFECTOR-Therapeutics-Initiates-Phase-1-2-Safety-and-Efficacy-Study-of-Zotatifin-eFT226-in-Patients-with-Advanced-Solid-Tumor-Malignancies.html' target='_blank'>Drug Company Press Release: eFT226 (Zotatifin)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Targeted Therapies for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/cddis2014542' target='_blank'>Journal Article: The Malignant Phenotype in Breast Cancer is Driven by eIF4A1-mediated Changes in The Translational Landscape</a> </li></ul>

10

eFT226 in Advanced Breast Cancer That Tests Positive for HER2, ERBB3, FGFR1, FGFR2, or KRAS Mutations

Show Scientific Title

A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Nearest Location:
28 miles
Stanford University
Palo Alto, CA

Visits:
1 visit per week, ongoing

ClinicalTrials.gov: NCT04092673

Phase I-II

11

PRO1184 Antibody Drug Conjugate for Advanced HER2- Breast Cancer that Expresses FRA

Show Scientific Title

Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of PRO1184, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer that expresses folate receptor alpha (FRA) who have received standard treatment. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRO1184, by IV</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRO1184 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">BB-1701's antibody targets folate receptor alpha (FRA), a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called exatecan.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: FRA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05579366' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/profoundbio-receives-fda-study-may-proceed-letter-for-pro1184-a-folate-receptor-alpha-directed-adc-with-a-topoisomerase-1-inhibitor-payload-and-welcomes-naomi-hunder-md-as-chief-medical-officer-301598943.html?tc=em' target='_blank'>ProfoundBio Press Release: PRO1184</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

11

PRO1184 Antibody Drug Conjugate for Advanced HER2- Breast Cancer that Expresses FRA

Show Scientific Title

Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors

Nearest Location:
53 miles
Providence Medical Foundation
Santa Rosa, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05579366

Phase I-II

12

AZD8205 for Advanced Triple Negative BreastCancer

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A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies

Purpose: To determine the safety, side effects, dose, and anti-cancer activity of AZD8205, and antibody-drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. You must not have received more than one line of therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8205, by IV</li> </ul> Please contact research site for treatment schedule.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05123482' target='_blank'>ClinicalTrials.gov</a> </li></ul>

12

AZD8205 for Advanced Triple Negative BreastCancer

Show Scientific Title

A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies

Nearest Location:
53 miles
Research Site
Santa Rosa, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05123482

Phase I-II

13

Belzutifan Targeted Therapy with Hormone Therapy for Advanced ER+, HER2- Breast Cancer

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A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (MK-6482-029/LITESPARK-029)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of belzutifan (MK-6482), an experimental targeted therapy, with hormone therapy compared to standard of care targeted therapy and hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received at least 1 line of hormone therapy for advanced disease. You must not have received chemotherapy or a PARP inhibitor for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental Targeted Therapy with Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> </ul> Group 2: Targeted Therapy with Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly or exemestane (Aromasin®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482) is an experimental targeted therapy called a HIF-2a inhibitor. Blocking HIF-2a may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482) is approved for use in other cancers. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06428396' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20240821/belzutifan-improves-pfs-response-in-advanced-renal-cell-carcinoma' target='_blank'>Healio: Belzutifan for Advanced Kidney Cancer</a> </li></ul>

13

Belzutifan Targeted Therapy with Hormone Therapy for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (MK-6482-029/LITESPARK-029)

Nearest Location:
186 miles
Renown Regional Medical Center ( Site 0018)
Reno, NV

Visits:
About 1 visit every month

ClinicalTrials.gov: NCT06428396

Phase II

14

Eniluracil Targeted Therapy with Chemotherapy for Advanced HER2- Breast Cancer

Show Scientific Title

A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of eniluracil (PCS6422), an experimental DPD inhibitor, with capecitabine (Xeloda®) compared to capecitabine (Xeloda®) alone.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have received chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eniluracil (PCS6422), 1 time</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eniluracil (PCS6422) is an experimental targeted therapy called a DPD inhibitor that, when combined with capecitabine (Xeloda®), may make the immune response more active against cancer.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06568692' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fixed-dose-eniluracil-under-investigation-in-advanced-refractory-gastrointestinal-cancers' target='_blank'>OncLive: Eniluracil for Advanced Gastrointestinal Cancers</a> </li></ul>

14

Eniluracil Targeted Therapy with Chemotherapy for Advanced HER2- Breast Cancer

Show Scientific Title

A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

Nearest Location:
304 miles
FOMAT Medical Research
Oxnard, CA

Visits:
1 visit every 3 months

ClinicalTrials.gov: NCT06568692

Phase II

15

Utidelone Chemotherapy for Metastatic HER2- or HER2 Low Breast Cancer with Brain Metastases

Show Scientific Title

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of utidelone (UTD1), an experimental chemotherapy, with capecitabine (Xeloda®) chemotherapy.

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain (brain metastases) who have received no more than 3 lines of chemotherapy for metastatic disease. You must not have leptomeningeal metastasis (leptomeningeal disease). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utidelone (UTD1), by injection, daily for 5 days, every 3 weeks</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utidelone (UTD1) is an experimental chemotherapy drug that may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is an FDA approved chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06764940' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/utd1-receives-fda-orphan-drug-designation-in-breast-cancer-brain-metastasis' target='_blank'>OncLive: UTD1 for Breast Cancer Brain Metastasis</a> </li></ul>

15

Utidelone Chemotherapy for Metastatic HER2- or HER2 Low Breast Cancer with Brain Metastases

Show Scientific Title

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases

Nearest Location:
304 miles
FOMAT Medical Research (Network)
Oxnard, CA

Visits:
At least 5 visits every 3 weeks

ClinicalTrials.gov: NCT06764940

Phase II

16

Invikafusp Alfa Immunotherapy with ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

Show Scientific Title

A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of STAR0602, an experimental immunotherapy, with sacituzumab govitecan (Trodelvy®) antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Invikafusp alfa (STAR0602), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Invikafusp alfa (STAR0602) is an experimental bispecific antibody that may target immune cells to stimulate anti-cancer activity.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06827613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

16

Invikafusp Alfa Immunotherapy with ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

Show Scientific Title

A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)

Nearest Location:
336 miles
UCLA Health
Los Angeles, CA

Visits:
At least 1 visit every 3 weeks

ClinicalTrials.gov: NCT06827613

Phase I-II

17

PMD-026 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2-, RSK2+ Breast Cancer

Show Scientific Title

Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients With Metastatic Breast Cancer With Expansion in Metastatic Triple Negative Breast Cancer

Purpose: To study the safety, best dose, and effects (good and bad) of PMD-026, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), RSK2 positive (RSK2+) breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026 is an experimental targeted therapy that targets RSK2, a protein that plays a role in cancer cell growth.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04115306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://phoenixmd.ca/pipeline' target='_blank'>Drug Company Information Page: PMD-026</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/29498411' target='_blank'>PubMed Abstract: RSK1 Promotes Murine Breast Cancer Growth and Metastasis</a> </li></ul>

17

PMD-026 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2-, RSK2+ Breast Cancer

Show Scientific Title

Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients With Metastatic Breast Cancer With Expansion in Metastatic Triple Negative Breast Cancer

Nearest Location:
336 miles
University of California, Los Angeles (UCLA)
Los Angeles, CA

Visits:
At least 1 visit every month

ClinicalTrials.gov: NCT04115306

Phase I-II

18

BRIA-OTS Cell Therapy for Metastatic Breast Cancer

Show Scientific Title

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of the Bria-OTS regimen, an experimental cell therapy, with tislelizumab (Tevimbra®) PD-1 inhibitor.

Who is this for?: People with metastatic (stage IV) breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following as part of the Bria-OTS regimen: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 2-3 days before BC1 cells</li> </ul> followed 2-3 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BC1 cells, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Peginterferon, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tislelizumab (Tevimbra®), every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Bria-OTS regimen is an experimental cell therapy with BC1 cells.</li> <li class="seamTextUnorderedListItem">Before you receive the cell therapy, you will receive cyclophosphamide (Cytoxan®) chemotherapy to prepare your body to receive the cells.</li> <li class="seamTextUnorderedListItem">Tislelizumab (Tevimbra®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Tislelizumab (Tevimbra®) is approved to treat other cancers. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Peginterferon is an immunotherapy used to regulate your immune response to the cell therapy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06471673' target='_blank'>ClinicalTrials.gov</a> </li></ul>

18

BRIA-OTS Cell Therapy for Metastatic Breast Cancer

Show Scientific Title

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

Nearest Location:
338 miles
Sarcoma Oncology Center
Santa Monica, CA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT06471673

Phase I-II

19

Dual PARP and Microtubule Polymerization Inhibitor AMXI-5001 for Advanced Breast Cancer.

Show Scientific Title

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies

Purpose: To study the best dose, safety, and anti-cancer activity of AMXI-5001--an experimental PARP inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AMXI-5001, by mouth, twice daily (4 days on, 3 days off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AMX-5001 is an experimental PARP inhibitor.</li> <li class="seamTextUnorderedListItem">PARP inhibitors block poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04503265' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://atlasmedx.com/product-pipeline/' target='_blank'>AtlasMedx Drug Information Page: AMXI-5001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/parp-inhibitor' target='_blank'>NCI Drug Dictionary: PARP Inhibitor</a> </li></ul>

19

Dual PARP and Microtubule Polymerization Inhibitor AMXI-5001 for Advanced Breast Cancer.

Show Scientific Title

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies

Nearest Location:
339 miles
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04503265

Phase I-II

20

A2B395 CAR T Cell Therapy for Advanced Breast Cancer That Expresses EGFR and Has Lost HLA Expression

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A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression (DENALI-1 (after BASECAMP-1))

Purpose: To study the safety, best dose, and effects (good and bad), and anti-cancer activity of A2B395, an experimental CAR T cell immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that expresses EGFR (EGFR+) and has lost HLA-A*02 expression. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A2B395</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To participate in this study, your tumor will be tested for EGFR and HLA by also enrolling into the BASECAMP-1 trial (NCT04981119).</li> <li class="seamTextUnorderedListItem">HLA-A*02 is a marker found on cancer cells that plays a role in how the immune system responds to cancer.</li> <li class="seamTextUnorderedListItem">EGFR (epidermal growth factor receptor) is a protein that is involved in cell growth and survival. </li> <li class="seamTextUnorderedListItem">A2B395 is an experimental CAR T cell immunotherapy.</li> <li class="seamTextUnorderedListItem">CAR T cell or CAR-T cell therapy is an immunotherapy made from white blood cells.</li> <li class="seamTextUnorderedListItem">The blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein on cancer cells.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">In this trial, the cells will attack cancer cells that express EGFR and have lost HLA-A*02 expression. Normal healthy cells will not be targeted.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06682793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy-mbc-2-2/' target='_blank'>Metastatic Trial Talk: Cell-Based Therapies: A Type of Immunotherapy for MBC</a> </li></ul>

20

A2B395 CAR T Cell Therapy for Advanced Breast Cancer That Expresses EGFR and Has Lost HLA Expression

Show Scientific Title

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression (DENALI-1 (after BASECAMP-1))

Nearest Location:
339 miles
UCLA Medical Center
Los Angeles, CA

Visits:
May require hospitalization

ClinicalTrials.gov: NCT06682793

Phase I-II

21

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

Show Scientific Title

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation (PYNNACLE)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of PC14586, an experimental p53 reactivator, alone or with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a TP53 Y220C mutation who have received at least 1 line of therapy. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586 is an experimental targeted therapy called a p53 reactivator which may stop the mutated p53 protein from working and cause cancer cell death.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53 Y220C</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04585750' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pmvpharma.com/pipeline/' target='_blank'>PMV Pharmaceuticals: PC14586 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

21

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

Show Scientific Title

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation (PYNNACLE)

Nearest Location:
339 miles
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04585750

Phase I-II

22

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors (ABILITY)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of MDNA11, an experimental immunotherapy, alone and with a checkpoint inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Checkpoint inhibitor as determined by your physician</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11 is an experimental immunotherapy called interleukin-2 (IL-2).</li> <li class="seamTextUnorderedListItem">IL-2 activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">A checkpoint inhibitor is a type of immunotherapy. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05086692' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medicenna.com/pipeline/mdna11/' target='_blank'>Medicenna Drug Information Page: MDNA11</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2021/12/22/2356750/0/en/Medicenna-Announces-Preliminary-Clinical-Data-Showing-Preferential-Stimulation-of-Anti-Cancer-Immune-Cells-with-MDNA11-Treatment-in-the-Phase-1-2-ABILITY-Study.html' target='_blank'>Medicenna Press Release: MDNA11 Treatment in the Phase 1/2 ABILITY Study</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cytokines' target='_blank'>Breastcancer.org: Interleukin-2</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-checkpoint-inhibitors' target='_blank'>Breastcancer.org: Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/checkpoint-inhibitors' target='_blank'>Cancer Research UK: Checkpoint Inhibitors</a> </li></ul>

22

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors (ABILITY)

Nearest Location:
339 miles
Providence Saint John's Health Center
Santa Monica, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05086692

Phase I-II

23

STX-001 mRNA Injection with Pembrolizumab for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab

Purpose: To study the safety, best dose, and effects (good and bad) of STX-001, an experimental mRNA drug, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received chemotherapy and pembrolizumab (Keytruda®) or dostarlimab (Jemperli®) for advanced disease. You must have at least 1 tumor that has not received radiation. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-001, by injection into tumor</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by injection, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-001 is an experimental mRNA drug. It contains genetic instructions that allow your body to produce interleukin-12 (IL-12). IL-12 activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06249048' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2022/mrna-vaccines-to-treat-cancer' target='_blank'>National Cancer Institute: Can mRNA Vaccines Help Treat Cancer?</a> </li></ul>

23

STX-001 mRNA Injection with Pembrolizumab for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab

Nearest Location:
340 miles
NextGen Oncology
Beverly Hills, CA

Visits:
At least 1 visit every 3 weeks

ClinicalTrials.gov: NCT06249048

Phase I-II

24

TransCon IL-2 β/γ Immunotherapy with Trastuzumab or Trastuzumab Emtansine (T-DM1) for Metastatic 3rd Line or Later HER2+ Breast Cancer

Show Scientific Title

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Purpose: To study the safety, best dose, and effects (good and bad) of TransCon IL-2 β/γ, an experimental immunotherapy, alone or with other anti-cancer therapies.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received at least 2 lines of therapy for metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TransCon IL-2 β/γ, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) or Trastuzumab emtansine (T-DM1, Kadcyla®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TransCon IL-2 β/γ is an experimental immunotherapy that includes interleukin-2 (IL-2) and may work better than IL-2 alone.</li> <li class="seamTextUnorderedListItem">IL-2 activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">T-DM1's antibody targets HER2 and delivers an anti-cancer drug called emtansine.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05081609' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascendispharma.com/pipeline/oncology/' target='_blank'>Ascendis Pharma: TransCon Drug Information Page</a> </li></ul>

24

TransCon IL-2 β/γ Immunotherapy with Trastuzumab or Trastuzumab Emtansine (T-DM1) for Metastatic 3rd Line or Later HER2+ Breast Cancer

Show Scientific Title

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Nearest Location:
340 miles
Ascendis Pharma Investigational Site
Los Angeles, CA

Visits:
At least 1 visit every 3 weeks

ClinicalTrials.gov: NCT05081609

Phase I-II

25

Izalontamab Brengitecan Versus Chemotherapy for Advanced Triple Negative or ER Low Breast Cancer

Show Scientific Title

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of izalontamab brengitecan, a bi-specific antibody-drug conjugate (ADC), compared to standard chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or estrogen receptor low (ER low) breast cancer who have not yet received treatment for their metastatic disease. You must be ineligible for anti-PD-1, anti-PD-L1, and hormone therapy. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Izalontamab brengitecan</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy</li></ul>

What's being studied?

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06926868' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bms.com/researchers-and-partners/in-the-pipeline.html' target='_blank'>Bristol Myers Squibb: Izalontamab brengitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li></ul>

25

Izalontamab Brengitecan Versus Chemotherapy for Advanced Triple Negative or ER Low Breast Cancer

Show Scientific Title

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

Nearest Location:
340 miles
Valkyrie Clinical Trials
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06926868

Phase II-III

26

Zongertinib Targeted Therapy with ADC for Advanced HER2+ Breast Cancer

Show Scientific Title

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) in Combination With Intravenous Trastuzumab Deruxtecan (T-DXd) or in Combination With Intravenous Trastuzumab Emtansine (T-DM1) for Treatment of Patients With Advanced HER2+ Metastatic Breast Cance...

Purpose: To find a dose of zongertinib, an experimental targeted therapy, that people with advanced HER2+ breast cancer can tolerate best when taken with trastuzumab deruxtecan (T-DXd, Enhertu®) or trastuzumab emtansine (T-DM1, Kadcyla®) antibody drug conjugates.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib (BI 1810631), by mouth</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®), by IV</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib (BI 1810631), by mouth</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib is an experimental anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) and trastuzumab emtansine (T-DM1, Kadcyla®) are antibody drug conjugates (ADCs).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®)'s antibody targets HER2 and delivers an anti-cancer drug called DM1.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06324357' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.boehringer-ingelheim.com/science/human-pharma/clinical-pipeline/oncology/zongertinib-her2-tyrosine-kinase-inhibitor-tki' target='_blank'>Boehringer Ingelheim: Zongertinib (BI 1810631) Drug Information Page</a> </li></ul>

26

Zongertinib Targeted Therapy with ADC for Advanced HER2+ Breast Cancer

Show Scientific Title

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) in Combination With Intravenous Trastuzumab Deruxtecan (T-DXd) or in Combination With Intravenous Trastuzumab Emtansine (T-DM1) for Treatment of Patients With Advanced HER2+ Metastatic Breast Cance...

Nearest Location:
340 miles
Valkyrie Clinical Trials
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06324357

Phase I-II

27

LCB84 Antibody Drug Conjugate With and Without Immunotherapy for Advanced Breast Cancer

Show Scientific Title

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of LCB84, an experimental antibody drug conjugate (ADC), with or without a PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84, by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">PD-1 inhibitor, by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">LCB84's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called MMAE.</li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy called immune checkpoint inhibitors. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05941507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/?utm_medium=email&utm_source=subscribers&utm_campaign=Oct2023&utm_content=Email102023' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/checkpoint-inhibitors' target='_blank'>National Cancer Institute: Immune Checkpoint Inhibitors</a> </li></ul>

27

LCB84 Antibody Drug Conjugate With and Without Immunotherapy for Advanced Breast Cancer

Show Scientific Title

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors

Nearest Location:
341 miles
Cedars Sinai Medical Center
Los Angeles, CA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT05941507

Phase I-II

28

Sacituzumab Govitecan ADC at a Different Dose and Schedule in Advanced Triple Negative Breast Cancer

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A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of a different dose and schedule of sacituzumab govitecan (Trodelvy), an antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment for advanced disease. Your tumors must be PD-L1 negative, or you must have received treatment with pembrolizumab (Keytruda) or atezolizumab (Tecentriq®) immunotherapy for early stage disease. You must not have received treatment with trastuzumab deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®) ADCs or irinotecan (Camptosar®) chemotherapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is FDA approved for advanced triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is studying a new way to give sacituzumab govitecan (Trodelvy®).</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers a chemotherapy drug to cancer cells with TROP2.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06926920' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

28

Sacituzumab Govitecan ADC at a Different Dose and Schedule in Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

Nearest Location:
346 miles
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06926920

Phase I-II

29

Ifinatamab Deruxtecan ADC for Advanced HER2 Low or HER2 Negative Breast Cancer

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A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Purpose: To study the safety, best dose, and effects (good and bad) of ifinatamab deruxtecan (I-DXd), an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low or HER2 negative (HER2-) breast cancer who have received at least 1 line of therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ifinatamab deruxtecan (I-DXd), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ifinatamab deruxtecan (I-DXd) is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Ifinatamab deruxtecan (I-DXd)'s antibody targets B7-H3, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+/ISH- or IHC 1+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06330064' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/january-2024/antibody-drug-conjugate-ifinatamab-deruxtecan-shows-robust-activity-in-refractory-small-cell-lung-cancer/' target='_blank'>ASCO: Antibody-Drug Conjugate Ifinatamab Deruxtecan for Small Cell Lung Cancer</a> </li></ul>

29

Ifinatamab Deruxtecan ADC for Advanced HER2 Low or HER2 Negative Breast Cancer

Show Scientific Title

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Nearest Location:
346 miles
Los Angeles Cancer Network
Los Angeles, CA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT06330064

Phase II

30

GDC-4198 CDK2/4/6 Inhibitor Plus Giredestrant Oral SERD Versus Abemaciclib Plus Giredestrant for Advanced ER+, HER2- Breast Cancer

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A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progre...

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of GDC-4198 CDK2/4/6 inhibitor and giredestrant oral SERD compared with abemaciclib (Verzenio®) CDK4/6 inhibitor and giredestrant.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have experienced disease progression during or after receiving a CDK4/6 inhibitor and hormone therapy. You must not have received more than 1 line of therapy or chemotherapy. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-4198, by mouth, daily, up to 3 years</li> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, up to 3 years</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, up to 3 years</li> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, up to 3 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-4198 is an experimental CDK2/4/6 inhibitor.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental hormone therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07100106' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://regor.com/#pipeline' target='_blank'>Regor Therapeutics: GDC-4198</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/medical-professionals/pipeline/giredestrant' target='_blank'>Genentech: Giredestrant</a> </li></ul>

30

GDC-4198 CDK2/4/6 Inhibitor Plus Giredestrant Oral SERD Versus Abemaciclib Plus Giredestrant for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progre...

Nearest Location:
353 miles
City of Hope
Duarte, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT07100106

Phase I-II

31

Zelenectide Pevedotin Targeted Therapy for Advanced HR+, HER2- or Triple Negative Breast Cancer That Expresses NECTIN4

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Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of zelenectide pevedotin, an experimental targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2- or HER2 low) or triple negative (ER- or ER low, PR-, HER2- or HER2 low) breast cancer that expresses NECTIN4. You must have received 1-3 lines of therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zelenectide pevedotin (BT8009), weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zelenectide pevedotin is an experimental targeted therapy called a bicycle drug conjugate (BDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">A bicycle drug conjugate (BDC) is a type of therapy that combines a drug that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Zelenectide pevedotin's antibody targets NECTIN4, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called MMAE.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+/ISH- or IHC 2/ISH-+.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06840483' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/pipeline/pipeline/' target='_blank'>Bicycle Therapeutics: Zelenectide Pevedotin Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/first-in-class-bicycle-toxin-conjugate-targeting-nectin-4-generates-excitement-in-urothelial-carcinoma' target='_blank'>OncLive: Zelenectide Pevedotin for Advanced Urinary Tract Cancer</a> </li></ul>

31

Zelenectide Pevedotin Targeted Therapy for Advanced HR+, HER2- or Triple Negative Breast Cancer That Expresses NECTIN4

Show Scientific Title

Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer

Nearest Location:
353 miles
City of Hope National Medical Center
Duarte, CA

Visits:
1 visit every 1-2 weeks

ClinicalTrials.gov: NCT06840483

Phase II

32

BAY2927088 Targeted Therapy for Advanced Breast Cancer with HER2 Mutations

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A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations (panSOHO)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of BAY2927088, an experimental targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a HER2 mutation who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAY2927088, by mouth, daily</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Heart tests</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancers have changes or mutations to a gene called human epidermal growth receptor 2 (HER2). These mutations can help the cancer grow.</li> <li class="seamTextUnorderedListItem">BAY2927088 is an experimental anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It may block abnormal HER2 which may slow or stop the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06760819' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/treatments/24984-tyrosine-kinase-inhibitors' target='_blank'>Cleveland Clinic: Tyrosine Kinase Inhibitors</a> </li></ul>

32

BAY2927088 Targeted Therapy for Advanced Breast Cancer with HER2 Mutations

Show Scientific Title

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations (panSOHO)

Nearest Location:
353 miles
City of Hope - Duarte Cancer Center
Duarte, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06760819

Phase II

33

Stereotactic Body Radiation Therapy and FES PET/CT Scans for Oligoprogressive Metastatic ER+ Breast Cancer

Show Scientific Title

A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of stereotactic body radiation therapy (SBRT) for oligoprogressive metastatic breast cancer.

Who is this for?: People with oligoprogressive metastatic (stage IV) estrogen receptor positive (ER+) breast cancer who have received 1-3 lines of therapy for metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT), 3-5 sessions within 3 weeks</li> <li class="seamTextUnorderedListItem">PET/CT scan with FES, by IV, 3-4 times within 6 months</li> <li class="seamTextUnorderedListItem">Bone scan</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oligoprogression refers to limited disease progression (1-4 metastases).</li> <li class="seamTextUnorderedListItem">Currently, the standard of care treatment for oligoprogressive disease is to change treatment when progression occurs.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors.</li> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses special equipment to position a patient and precisely deliver radiation. The total dose of radiation is divided into smaller doses (fractions) given over several days.</li> <li class="seamTextUnorderedListItem">SBRT helps keep normal tissue healthy and has been shown to improve survival.</li> <li class="seamTextUnorderedListItem">This trial also tests how well PET/CT scans with FES works in identifying progressive disease.</li> <li class="seamTextUnorderedListItem">FES is a radioactive substance that binds to estrogen receptors and gives off radiation that can be detected by a PET scan.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06260033' target='_blank'>ClinicalTrials.gov</a> </li></ul>

33

Stereotactic Body Radiation Therapy and FES PET/CT Scans for Oligoprogressive Metastatic ER+ Breast Cancer

Show Scientific Title

A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer

Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

Visits:
At least 6-9 visits within 6 months

ClinicalTrials.gov: NCT06260033

Phase II

34

Patritumab Deruxtecan for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of patritumab deruxtecan (HER3-DXd), an antibody-drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received treatment with chemotherapy, a CDK 4/6 inhibitor, and hormone therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan (HER3-DXd), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan (HER3-DXd) is an antibody-drug conjugate that targets HER3.</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06172478' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.daiichisankyo.com/rd/pipeline/' target='_blank'>Daiichi Sankyo: Patritumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li></ul>

34

Patritumab Deruxtecan for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Nearest Location:
353 miles
City of Hope
Duarte, CA

Visits:
Every 3 weeks

ClinicalTrials.gov: NCT06172478

Phase II

35

APL-5125 Targeted Therapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of APL-5125, an experimental kinase inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">APL-5125, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">APL-5125 is a type of targeted therapy called a kinase inhibitor. It blocks an enzyme that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06399757' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.apollotx.com/pipeline/' target='_blank'>Apollo Therapeutics: APL-5125 Drug Information Page</a> </li></ul>

35

APL-5125 Targeted Therapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

Nearest Location:
353 miles
City of Hope
Duarte, CA

Visits:
1 visit every 2-3 months

ClinicalTrials.gov: NCT06399757

Phase I-II

36

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

Show Scientific Title

A Phase IIA Trial Assessing the Tolerability of Abemaciclib Monotherapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer

Purpose: To study the side effects (good and bad) of abemaciclib (Verzenio®).

Who is this for?: People with metastatic (stage IV), hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are age 70 or older and have already received treatment for metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04305834' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com' target='_blank'>Drug Company Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/breast-cancer-elderly-how-bcrf-researchers-are-treating-growing-patient-population' target='_blank'>Breast Cancer Research Foundation: Breast Cancer in the Elderly</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249663/' target='_blank'>Journal Article: Use of Cyclin-Dependent Kinase 4/6 (CDK4/6) Inhibitors in Older Patients</a> </li></ul>

36

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

Show Scientific Title

A Phase IIA Trial Assessing the Tolerability of Abemaciclib Monotherapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer

Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04305834

Phase II

37

GM1 to Reduce or Prevent Nerve Pain During Chemotherapy for Metastatic Breast Cancer

Show Scientific Title

An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy

Purpose: To study the ability of GM1 to reduce or prevent nerve pain during treatment with paclitaxel (Taxol®) chemotherapy.

Who is this for?: People with metastatic (stage IV) breast cancer who are planning to receive treatment with paclitaxel (Taxol®) chemotherapy. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GM1, by IV, weekly for 4 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 4 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for GM1, by IV, weekly for 4 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 4 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neuropathy is nerve pain in your hands and feet as a side effect of cancer treatment such as chemotherapy.</li> <li class="seamTextUnorderedListItem">GM1 is a part of the body's natural system that protects nerves from damage.</li> <li class="seamTextUnorderedListItem">Chemotherapy drugs, such as paclitaxel (Taxol®), work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or stopping them from spreading.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05751668' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>

37

GM1 to Reduce or Prevent Nerve Pain During Chemotherapy for Metastatic Breast Cancer

Show Scientific Title

An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy

Nearest Location:
374 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, CA

Visits:
1 visit every week for 4 months

ClinicalTrials.gov: NCT05751668

Phase II

38

MRT-2359 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of MRT-2359, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRT-2359, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRT-2359 is an experimental targeted therapy called a molecular glue degrader (MGD). Molecular glue degrader (MGD) may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05546268' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.monterosatx.com/queen/' target='_blank'>Monte Rosa Therapeutics: MRT-2359 Drug Information Page</a> </li></ul>

38

MRT-2359 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma

Nearest Location:
381 miles
Hoag Memorial Hospital Presbyterian
Newport Beach, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05546268

Phase I-II

39

ENV-501 Antibody Drug Conjugate for Advanced HR+, HER2-, HER3+ Breast Cancer

Show Scientific Title

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ENV-501, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), HER3 positive (HER3+) breast cancer who have no standard treatment options available. You must not have received trastuzumab deruxtecan (Enhertu®) as your most recent line of therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ENV-501, by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ENV-501 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody targets cancer cells, the ADC does minimal damage to normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in disitamab vedotin targets HER3 proteins. It delivers the chemotherapy exatecan.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06956690' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://endeavorbiomedicines.com/our-science/env-501/' target='_blank'>Endeavor Biomedicines: ENV-501 Drug Information Page</a> </li></ul>

39

ENV-501 Antibody Drug Conjugate for Advanced HR+, HER2-, HER3+ Breast Cancer

Show Scientific Title

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors

Nearest Location:
441 miles
Research Site
La Jolla, CA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT06956690

Phase I-II

40

Cognitive-Sparing Stereotactic Radiosurgery for Brain Metastasis

Show Scientific Title

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of cognitive-sparing stereotactic radiosurgery.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive-sparing stereotactic radiosurgery</li> <li class="seamTextUnorderedListItem">MRI scans, 4 scans within 6 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive tests</li> </ul> Please contact research site for treatment schedule.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Cognitive-sparing stereotactic radiosurgery is a targeted radiation therapy that avoids the white matter and hippocampus (parts of the brain that control memory, language, attention, and cognition).</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04343157' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

40

Cognitive-Sparing Stereotactic Radiosurgery for Brain Metastasis

Show Scientific Title

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions

Nearest Location:
447 miles
Moores Cancer Center
San Diego, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04343157

Phase II

41

Gadolinium and Ferumoxytol with MRI Scans for Brain Metastasis

Show Scientific Title

The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS

Purpose: To use ferumoxytol and gadolinium to improve the ability of MRI scans to image, diagnose, and study brain metastasis.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gadolinium, by IV</li> <li class="seamTextUnorderedListItem">Ferumoxytol, by IV</li> <li class="seamTextUnorderedListItem">MRI scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">Ferumoxytol and gadolinium can increase the visibility of body structures in imaging such as MRI scans.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03270059' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://mriquestions.com/ferumoxytol.html' target='_blank'>MRI Questions: Ferumoxytol</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-gadolinium-based-contrast-agents' target='_blank'>Food and Drug Administration: Gadolinium</a> </li></ul>

41

Gadolinium and Ferumoxytol with MRI Scans for Brain Metastasis

Show Scientific Title

The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS

Nearest Location:
533 miles
OHSU Knight Cancer Institute
Portland, OR

Visits:
3 visits within 6 weeks

ClinicalTrials.gov: NCT03270059

Phase II

42

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer

Show Scientific Title

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, MTD/RP2D, and Antitumor Activity of ARTS-021 as a Single Agent and in Combination Therapy in Patients With Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARTS-021, an experimental CDK2 inhibitor, alone or with other anti-cancer drugs.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. View full eligibility criteria

What's involved?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) or letrozole (Femara®)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05867251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/' target='_blank'>Avenzo Therapeutics: ARTS-021 Drug and Trial Information Page</a> </li></ul>

42

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer

Show Scientific Title

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, MTD/RP2D, and Antitumor Activity of ARTS-021 as a Single Agent and in Combination Therapy in Patients With Solid Tumors

Nearest Location:
538 miles
Providence Cancer Institute
Portland, OR

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05867251

Phase I-II

43

Zanidatamab Targeted Therapy for Advanced HER2 Positive Breast Cancer

Show Scientific Title

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab, an experimental targeted therapy.

Who is this for?: People with advanced HER2 positive (HER2+ (IHC3+)) breast cancer who have received trastuzumab deruxtecan (T-DXd, Enhertu®) and have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (ZW25) is an experimental anti-HER2 targeted therapy and bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 positive is IHC 3+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06695845' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zymeworks.com/pipeline#zanidatamab' target='_blank'>Zymeworks Drug Information Page: Zanidatamab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/dr-montero-on-zanidatamab-and-evorpacept-in-her2-expressing-metastatic-breast-cancer' target='_blank'>OncLive: Zanidatamab for Metastatic HER2+ Breast Cancer</a> </li></ul>

43

Zanidatamab Targeted Therapy for Advanced HER2 Positive Breast Cancer

Show Scientific Title

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

Nearest Location:
597 miles
Arizona Oncology Associates, PC - NAHOA
Prescott, AZ

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06695845

Phase II

44

ETX-19477 PARG Inhibitor for Advanced Breast Cancer

Show Scientific Title

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies (ERADIC8)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ETX-19477, an experimental PARG inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ETX-19477, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ETX-19477 is experimental targeted therapy called a PARG (poly ADP ribose glycohydrolase) inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking PARG may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06395519' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://8five8tx.com/pipeline' target='_blank'>858 Therapeutics: ETX-19477 Drug Information Page</a> </li></ul>

44

ETX-19477 PARG Inhibitor for Advanced Breast Cancer

Show Scientific Title

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies (ERADIC8)

Nearest Location:
602 miles
START Center for Cancer Care - Mountain Region
Salt Lake City, UT

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06395519

Phase I-II

45

Exercise for Fatigue for People with Advanced Breast Cancer Receiving Trastuzumab Deruxtecan

Show Scientific Title

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Purpose: To study the safety and effects (good and bad) of a home-based, unsupervised exercise program for cancer-related fatigue.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), HER2-low, or hormone receptor-positive (HR+), HER2-low or HER2-ultralow breast cancer who are receiving trastuzumab deruxtecan (Enhertu®) and experiencing fatigue. You must not be participating in an exercise program as defined by the study investigators. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise program, at home, for 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Physical function tests</li> </ul> Group 2: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No exercise</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Physical function tests</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The exercise program is an individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise program.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07203378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/special-topics/enhertu-hrpos-her2low/' target='_blank'>Metastatic Trial Talk: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/fatigue-2/' target='_blank'>Metastatic Trial Talk: Fatigue</a> </li></ul>

45

Exercise for Fatigue for People with Advanced Breast Cancer Receiving Trastuzumab Deruxtecan

Show Scientific Title

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Nearest Location:
602 miles
Huntsman Cancer Institute at University of Utah
Salt Lake City, UT

Visits:
Number of visits unavailable, 3 months

ClinicalTrials.gov: NCT07203378

Phase II

46

JAB-2485 Targeted Therapy for Advanced ER+, Triple Negative, or ARID1A Mutated Breast Cancer

Show Scientific Title

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of JAB-2485, an experimental Aurora A inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) ER positive (ER+), triple negative (ER-, PR-, HER2-), or ARID1A mutated breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">JAB-2485, by mouth</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">JAB-2485 is an experimental targeted therapy called an Aurora A inhibitor. Aurora A inhibitors may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ARID1A</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05490472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/aurora-a-kinase-inhibitor-jab-2485' target='_blank'>National Cancer Institute: JAB-2485</a> </li></ul>

46

JAB-2485 Targeted Therapy for Advanced ER+, Triple Negative, or ARID1A Mutated Breast Cancer

Show Scientific Title

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors

Nearest Location:
602 miles
University of Utah Huntsman Cancer Institute
Salt Lake City, UT

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05490472

Phase I-II

47

Headband to Treat Thinking Problems for Stage I-IV Breast Cancer

Show Scientific Title

A Phase II, Double-blind, Randomized, Cross-over Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients

Purpose: To study the safety and effects (good and bad) of wearing a headband that contains a semiconductor for cancer-related cognitive impairment (thinking problems).

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are having cognitive (thinking) problems. You must not be planning to receive chemotherapy during this study. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Headband with semiconductor, 18 hours per day for 3 weeks</li> <li class="seamTextUnorderedListItem">No headband, 2 weeks</li> <li class="seamTextUnorderedListItem">Headband without semiconductor, 18 hours per day for 3 weeks</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Headband without semiconductor, 18 hours per day for 3 weeks</li> <li class="seamTextUnorderedListItem">No headband, 2 weeks</li> <li class="seamTextUnorderedListItem">Headband with semiconductor, 18 hours per day for 3 weeks</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some people who receive treatments for breast cancer experience cognitive problems.</li> <li class="seamTextUnorderedListItem">Cognitive tests measure your ability to think.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07173101' target='_blank'>ClinicalTrials.gov</a> </li></ul>

47

Headband to Treat Thinking Problems for Stage I-IV Breast Cancer

Show Scientific Title

A Phase II, Double-blind, Randomized, Cross-over Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients

Nearest Location:
602 miles
Huntsman Cancer Institute at University of Utah
Salt Lake City, UT

Visits:
Number of visits unavailable, 4 months

ClinicalTrials.gov: NCT07173101

Phase II

48

INX-315 CDK2 Inhibitor for Advanced ER+, HER2- or CCNE1 Amplified Breast Cancer

Show Scientific Title

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of INX-315, an experimental CDK2 inhibitor, alone or with other anti-cancer therapies.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK4/6 inhibitor or CCNE1 amplified breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups based on your type of cancer: Group 1: CCNE1 Amplified Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> </ul> Group 2: ER Positive, HER2 Negative Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degrader (SERD) hormone therapy (standard of care)</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitor (standard of care)</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degraders (SERD) are a type of hormone therapy that bind to and break down estrogen receptors. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are a type of targeted therapy that block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CCNE1</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05735080' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://incyclixbio.com/our-science/' target='_blank'>Incyclix Bio Drug Information Page: INX-315</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy and SERDs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: The Latest Research on CDK 4/6 Inhibitors</a> </li></ul>

48

INX-315 CDK2 Inhibitor for Advanced ER+, HER2- or CCNE1 Amplified Breast Cancer

Show Scientific Title

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Nearest Location:
656 miles
Northwest Medical Specialties, PLLC
Tacoma, WA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05735080

Phase I-II

49

2 Types of Stereotactic Radiosurgery for Brain Metastasis

Show Scientific Title

Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of two different types of stereotactic radiosurgery.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) that has not been treated with whole brain radiation. You are eligible if you have at least one brain lesion that has not been yet been treated with radiation. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Single Fraction Stereotactic Radiosurgery, 1 session</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fractionated Stereotactic Radiosurgery, 2-5 sessions</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> </ul> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery or stereotactic radiotherapy) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> </ul> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Single Fraction Stereotactic Radiosurgery (SFSR) is stereotactic radiation received in one higher dose of radiation given on one day of treatment.</li> </ul> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fractionated Stereotactic Radiation Therapy (FSRT) is stereotactic radiation is divided into several smaller doses (typically 2-5 sessions) of radiation given on separate days of treatment.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05222620' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/radiotherapy/external/types/stereotactic-body-radiotherapy-sbrt' target='_blank'>CancerResearchUK: Stereotactic Radiotherapy (SRT)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li></ul>

49

2 Types of Stereotactic Radiosurgery for Brain Metastasis

Show Scientific Title

Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)

Nearest Location:
660 miles
Mayo Clinic in Arizona
Scottsdale, AZ

Visits:
1-5 radiation sessions, then 1 visit every 3-6 months for 5 years

ClinicalTrials.gov: NCT05222620

Phase II

50

Targeted Therapy and Chemotherapy for Advanced HER2+ Breast Cancer

Show Scientific Title

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab (Herceptin®) anti-HER2 targeted therapy, tucatinib (Tukysa®) tyrosine kinase inhibitor, and eribulin (Halaven®) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with trastuzumab (Herceptin®) and chemotherapy for advanced/metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug approved to treat metastatic breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05458674' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>

50

Targeted Therapy and Chemotherapy for Advanced HER2+ Breast Cancer

Show Scientific Title

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer

Nearest Location:
679 miles
Swedish Cancer Institute
Issaquah, WA

Visits:
1 visit every 1-2 weeks

ClinicalTrials.gov: NCT05458674

Phase II

51

TUB-030 Antibody Drug Conjugate for Advanced Triple Negative and HR+, HER2- Breast Cancer

Show Scientific Title

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01)

Purpose: To study the safety, best dose, and effects (good and bad) of TUB-030, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) and hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TUB-030, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TUB-030 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody targets cancer cells, the ADC does minimal damage to normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in TUB-030 targets 5T4 proteins. It delivers the chemotherapy exatecan.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06657222' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tubulis.com/our-pipeline/' target='_blank'>Tubulis: TUB-030 Drug Information Page</a> </li></ul>

51

TUB-030 Antibody Drug Conjugate for Advanced Triple Negative and HR+, HER2- Breast Cancer

Show Scientific Title

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01)

Nearest Location:
682 miles
Fred Hutchinson Cancer Center
Seattle, WA

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT06657222

Phase I-II

52

STEMVAC Experimental Vaccine Plus Hormone Therapy or Capecitabine for Metastatic HR+, HER2- or HER2 Low Breast Cancer

Show Scientific Title

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental vaccine called STEMVAC in combination with standard hormone therapy or capecitabine (Xeloda®).

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer. You must be receiving hormone therapy and a CDK4/6 inhibitor, or have become resistant to hormone therapy and have received at least one cycle of capecitabine (Xeloda®). View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups: Group 1: Hormone Therapy Sensitive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">STEMVAC, by injection, 5 times within 9 months, then every 6 months</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> </ul> Group 2: Hormone Therapy Resistant <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth</li> <li class="seamTextUnorderedListItem">STEMVAC, by injection, 5 times within 9 months, then every 6 months</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> <li class="seamTextUnorderedListItem">FES PET scan</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The STEMVAC vaccine targets proteins expressed on breast cancer stem cells and may boost the ability of the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Hormone therapy blocks the effects of estrogen to block the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07112053' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/vaccines-mbc/' target='_blank'>Metastatic Trial Talk: Vaccines for MBC</a> </li></ul>

52

STEMVAC Experimental Vaccine Plus Hormone Therapy or Capecitabine for Metastatic HR+, HER2- or HER2 Low Breast Cancer

Show Scientific Title

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer

Nearest Location:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

Visits:
Number of visits unavailable, up to 3 years

ClinicalTrials.gov: NCT07112053

Phase II

53

Radiation to Reduce Side Effects for People with Metastatic Breast Cancer with Leptomeningeal Metastases

Show Scientific Title

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

Purpose: To study if radiation to the brain and spinal cord is an effective treatment while also reducing side effects for people with leptomeningeal metastases.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the leptomeninges (leptomeningeal disease). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation to brain and spinal cord, 10 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Lumbar puncture to collect CSF</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Questionnaires, 4 times in 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy can reduce symptoms of leptomeningeal metastases.</li> <li class="seamTextUnorderedListItem">However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease.</li> <li class="seamTextUnorderedListItem">Craniospinal irradiation (CSI) is radiation therapy directed at the brain and spinal cord. It may be able to target all potential areas of leptomeningeal tumor spread.</li> <li class="seamTextUnorderedListItem">It may also reduce side effects of radiation because it avoids the part of the brain called the hippocampus.</li> <li class="seamTextUnorderedListItem">Cerebrospinal fluid (CSF) is the fluid that surrounds your brain and spinal cord. CSF is typically collected during a procedure called a lumbar puncture, also known as a spinal tap.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06518057' target='_blank'>ClinicalTrials.gov</a> </li></ul>

53

Radiation to Reduce Side Effects for People with Metastatic Breast Cancer with Leptomeningeal Metastases

Show Scientific Title

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

Nearest Location:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

Visits:
10 visits within 2 weeks

ClinicalTrials.gov: NCT06518057

Phase II

54

Losartan to Reduce Fibrosis for People with Stage 0-IV Breast Cancer

Show Scientific Title

A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Purpose: To study the ability of losartan to decrease fibrosis from radiation.

Who is this for?: Women with stage 0 (DCIS), stage I, stage II, stage III, and stage IV (metastatic) breast cancer who have received surgery and are planning to receive radiation. Your breast cancer must not have recurred (came back), and you must not have received radiation. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Losartan, by mouth, daily during radiation until 1 year after radiation</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for losartan, by mouth, daily during radiation until 1 year after radiation</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Losartan is an FDA approved blood pressure medication that may also decrease fibrosis.</li> <li class="seamTextUnorderedListItem">Fibrosis is the thickening or scarring of tissue and can be caused by radiation.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05637216' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/types/breast-cancer/non-cancerous-breast-conditions/fibrosis-and-simple-cysts-in-the-breast.html#:~:text=Neither%20fibrosis%20nor%20simple%20cysts,is%20found%20on%20a%20biopsy.' target='_blank'>American Cancer Society: Breast Fibrosis</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a695008.html' target='_blank'>Medline Plus: Losartan</a> </li></ul>

54

Losartan to Reduce Fibrosis for People with Stage 0-IV Breast Cancer

Show Scientific Title

A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Nearest Location:
860 miles
Vail Health Shaw Cancer Center
Edwards, CO

Visits:
7 visits within 2 years

ClinicalTrials.gov: NCT05637216

Phase II

55

EIK1004 Targeted Therapy for Advanced Breast Cancer with HRR Mutations

Show Scientific Title

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors (EIK1004-001)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of EIK1004 (IMP1707), an experimental PARP1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have not ever received chemotherapy and hormone therapy (if hormone receptor positive). You must have a BRCA1, BRCA2, PALB2, ATM, or CHEK2 gene mutation. You must not have received more than 1 PARP inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EIK1004 (IMP1707), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EIK1004 is an experimental targeted therapy called a PARP1 inhibitor.</li> <li class="seamTextUnorderedListItem">PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">BRCA1, BRCA2, PALB2, ATM, and CHEK2 gene mutations are homologous recombination repair (HRR) or homologous recombination deficient (HRD) mutations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06907043' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

55

EIK1004 Targeted Therapy for Advanced Breast Cancer with HRR Mutations

Show Scientific Title

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors (EIK1004-001)

Nearest Location:
948 miles
Sarah Cannon Research Institute at HealthOne
Denver, CO

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06907043

Phase I-II

56

SMP-3124LP Targeted Therapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults with Advanced Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of SMP-3124LP, an experimental CHK1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SMP-3124LP, by IV, every 2-3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SMP-3124LP is an experimental targeted therapy called a CHK1 inhibitor. Blocking CHK1 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06526819' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sumitomo-pharma.com/rd/pipeline_new-medicine/pipeline_profile.html' target='_blank'>Sumitomo Pharma America: SMP-3124 Drug Information Page</a> </li></ul>

56

SMP-3124LP Targeted Therapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults with Advanced Solid Tumors

Nearest Location:
948 miles
Sarah Cannon Research Institute at HealthOne
Denver, CO

Visits:
1 visit every 2-3 weeks

ClinicalTrials.gov: NCT06526819

Phase I-II

57

MDX2001 Immunotherapy for Advanced Breast Cancer

Show Scientific Title

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of MDX2001, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDX2001, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDX2001 is an experimental immunotherapy called a tetraspecific antibody. MDX2001 may help target the immune system to help identify and kill tumor cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06239194' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.modextherapeutics.com/pipeline/' target='_blank'>ModeX Therapeutics: MDX2001 Drug Information Page</a> </li></ul>

57

MDX2001 Immunotherapy for Advanced Breast Cancer

Show Scientific Title

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors

Nearest Location:
948 miles
Sarah Cannon Research Institute
Denver, CO

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06239194

Phase I-II

58

MK-5684 Hormone Therapy for Advanced HR+ Breast Cancer

Show Scientific Title

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

Purpose: To compare the anti-cancer activity of MK-5684 hormone therapy to the standard of care hormone therapy treatment.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose cancer has progressed during or after at least one line of hormone therapy. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-5684, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fludrocortisone, by mouth</li> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of fulvestrant (Faslodex®), by injection, monthly or exemestane (Aromasin®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06979596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: MK-5684</a> </li></ul>

58

MK-5684 Hormone Therapy for Advanced HR+ Breast Cancer

Show Scientific Title

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

Nearest Location:
1298 miles
Mary Lanning Healthcare ( Site 0019)
Hastings, NE

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06979596

Phase II

59

Evorpacept Targeted Therapy with Standard of Care Treatment for Advanced HER2+ Breast Cancer

Show Scientific Title

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of evorpacept, an experimental targeted therapy, with standard of care treatment compared to standard of care treatment alone.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received trastuzumab deruxtecan (Enhertu®, T-DXd). View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept is an experimental targeted therapy called a CD47 inhibitor that allows immune cells to attack and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">This study is enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07007559' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://alxoncology.com/our-approach/evorpacept/' target='_blank'>ALX Oncology: Evorpacept Drug Information Page</a> </li></ul>

59

Evorpacept Targeted Therapy with Standard of Care Treatment for Advanced HER2+ Breast Cancer

Show Scientific Title

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

Nearest Location:
1414 miles
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, NE

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT07007559

Phase I-II

60

Local Chemotherapy to Prevent a Recurrence of Brain Metastases After Surgery

Show Scientific Title

A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease

Purpose: To compare local chemotherapy (Gliadel Wafer®) with stereotactic radiosurgery (SRS), after surgery, to prevent brain metastases from recurring.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) with at least one tumor requiring surgery. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups: Group 1: Gliadel <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove the metastatic brain tumor</li> <li class="seamTextUnorderedListItem">Placement of Gliadel Wafers (chemotherapy) in the surgical site after the tumor is removed</li> <li class="seamTextUnorderedListItem">MRIs, before and after surgery</li> </ul> Group 2: Standard care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove the metastatic brain tumor</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS) to the tumor site, within 6 weeks after surgery</li> <li class="seamTextUnorderedListItem">MRIs, before and after surgery</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy. </li> <li class="seamTextUnorderedListItem">Gliadel Wafer® is an implant that dissolves slowly and releases chemotherapy directly into the area where the brain tumor has been removed. It has been approved for certain types of brain tumors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04222062' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-20903/gliadel-wafer-implant/details' target='_blank'>WebMD: Gliadel Wafer</a> </li></ul>

60

Local Chemotherapy to Prevent a Recurrence of Brain Metastases After Surgery

Show Scientific Title

A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease

Nearest Location:
1418 miles
University of Nebraska Medical Center
Omaha, NE

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04222062

Phase II

61

Alpelisib and Anti-Hormone Therapy for Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation

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A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Purpose: To study the anti-cancer activity, safety, and side effects of giving the targeted therapy alpelisib (Piqray®) with an anti-hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that tests positive for a PIK3CA mutation. In addition, you must have already received a CDK 4/6 inhibitor, and you must not have received more than two anti-hormone therapies for metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Your doctor's choice of anti-hormone therapy, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04762979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/lines-of-therapy-mbc/' target='_blank'>Metastatic Trial Talk: Lines of Therapy for MBC</a> </li></ul>

61

Alpelisib and Anti-Hormone Therapy for Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation

Show Scientific Title

A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Nearest Location:
1418 miles
University of Nebraska Medical Center
Omaha, NE

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04762979

Phase II

62

Tucatinib Targeted Therapy and Doxil Chemotherapy for Advanced HER2+ Breast Cancer

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Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of tucatinib (Tukysa®) tyrosine kinase inhibitor with doxorubicin (Doxil®) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received anti-HER2 targeted therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a chemotherapy drug commonly used to treat breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05748834' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/doxil' target='_blank'>Breastcancer.org: Doxorubicin (Doxil®)</a> </li></ul>

62

Tucatinib Targeted Therapy and Doxil Chemotherapy for Advanced HER2+ Breast Cancer

Show Scientific Title

Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer

Nearest Location:
1478 miles
Texas Oncology- San Antonio
San Antonio, TX

Visits:
1 visit every month

ClinicalTrials.gov: NCT05748834

Phase II

63

BNT323 ADC and BNT327 Immunotherapy for Advanced HER2 Low, HER2 Ultra Low, and HER2 Negative Breast Cancer

Show Scientific Title

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of BNT323, an experimental antibody drug conjugate (ADC), and/or BNT327, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low, HER2 ultralow, and HER2 negative (HER2-) breast cancer. You must not have received treatment with trastuzumab deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®) ADCs or irinotecan (Camptosr®) chemotherapy. View full eligibility criteria

What's involved?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT323, by IV</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT327, by IV</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT323, by IV</li> <li class="seamTextUnorderedListItem">BNT327, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT323 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in BNT323 targets HER2 proteins. It delivers a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">BNT327 is an experimental targeted therapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to 2 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">BNT327 binds to PD-L1 and VEGF.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC1+ or IHC 2+/ISH-.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06827236' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.biontech.com/trials/BNT323-03?utm_source=chatgpt.com' target='_blank'>BioNTech: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='file:///Users/alexandraburd/Downloads/BNT_Factsheet_BNT323DB_1303_RZ_EN.pdf' target='_blank'>BioNTech: BNT323 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li></ul>

63

BNT323 ADC and BNT327 Immunotherapy for Advanced HER2 Low, HER2 Ultra Low, and HER2 Negative Breast Cancer

Show Scientific Title

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer

Nearest Location:
1481 miles
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, TX

Visits:
At least 11 visits every 2 weeks

ClinicalTrials.gov: NCT06827236

Phase I-II

64

AZD6750 Immunotherapy for Advanced Triple Negative Breast Cancer

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A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of AZD6750 immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received standard of care therapies. You must not have brain metastases that are untreated, unstable, or causing symptoms. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6750, by IV, up to 2 years</li> <li class="seamTextUnorderedListItem">Biopsy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6750 is an immunotherapy drug. Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07115043' target='_blank'>ClinicalTrials.gov</a> </li></ul>

64

AZD6750 Immunotherapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Nearest Location:
1481 miles
Research Site
San Antonio, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT07115043

Phase I-II

65

Increasing Doses of Stereotactic Radiation Therapy for People with Six or More Brain Metastases

Show Scientific Title

Phase I/II Trial to Determine the Neurocognitive Decline in Patients With Multiple (>6) Brain Metastases Treated With Distributed Stereotactic Radiosurgery

Purpose: To study the safety, anti-cancer activity, and side effects of giving increasing doses of stereotactic radiation therapy to multiple brain metastases.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and with six or more brain metastases. You must not have already received whole-brain radiation therapy or stereotactic radiation therapy for the brain metastases being treated in this trial. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotacitc radiation therapy for your brain metastases</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy. </li> <li class="seamTextUnorderedListItem">Whole-brain radiation therapy (WBRT) treats the entire brain, even tumors that may be too small to see with an MRI.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03508752' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>

65

Increasing Doses of Stereotactic Radiation Therapy for People with Six or More Brain Metastases

Show Scientific Title

Phase I/II Trial to Determine the Neurocognitive Decline in Patients With Multiple (>6) Brain Metastases Treated With Distributed Stereotactic Radiosurgery

Nearest Location:
1509 miles
University of Texas Southwestern Medical Center
Dallas, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT03508752

Phase I-II

66

Fulvestrant With Abemaciclib for ER+ or ER Low, HER2- Metastatic Breast Cancer

Show Scientific Title

Multicenter Randomized Phase II Trial of Fulvestrant Plus Abemaciclib With or Without Run-in of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer After Failure of a CDK4/6 Inhibitor In Combination With an Aromatase Inhibitor

Purpose: To determine if stopping treatment with abemaciclib (Verzenio®) for 1 month (called a drug holiday) improves the effects (good and bad) and anti-cancer activity of abemaciclib (Verzenio®) with fulvestrant (Faslodex®).

Who is this for?: Women with metastatic (stage IV) ER positive (ER+) or ER Low (1%-10% ER), HER2 negative (HER2-) breast cancer that has progressed on a CDK4/6 inhibitor in combination with an aromatase inhibitor immediately before enrolling in this study. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then once a month </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). It is approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">A drug holiday is a planned period of time that you decide with your doctor to stop taking a medication. In some cases, a drug holiday can allow a medication to become effective again.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put you in temporary menopause.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05305924' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/drug-holiday-definition-risks-and-benefits-2248870' target='_blank'>Verywell Health: Drug Holiday</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/pathology-report/hormone-receptor-status' target='_blank'>Breastcancer.org: Hormone Receptor Status</a> </li></ul>

66

Fulvestrant With Abemaciclib for ER+ or ER Low, HER2- Metastatic Breast Cancer

Show Scientific Title

Multicenter Randomized Phase II Trial of Fulvestrant Plus Abemaciclib With or Without Run-in of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer After Failure of a CDK4/6 Inhibitor In Combination With an Aromatase Inhibitor

Nearest Location:
1643 miles
Houston Methodist Cancer Center
Houston, TX

Visits:
2 visits the first month, then 1 visit a month, ongoing

ClinicalTrials.gov: NCT05305924

Phase II

67

Stereotactic Radiosurgery for People with Metastatic Breast Cancer with Brain Metastases

Show Scientific Title

EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active Systemic Therapy Options

Purpose: To learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who have at least 1 brain lesion that has not received radiation. You must be planning to receive chemotherapy or targeted therapy as the first treatment for brain mets. View full eligibility criteria

What's involved?

You will receive the following after receiving chemotherapy or targeted therapy: Group 1: Tumors Completely Disappear (Complete Response) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No radiation</li> <li class="seamTextUnorderedListItem">Brain MRIs</li> </ul> Group 2: Tumors Shrink (Partial Response) or Stay the Same (Stable Disease) You will be randomly assigned to 1 of the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No radiation</li> <li class="seamTextUnorderedListItem">Brain MRIs</li> </ul> Group 3: Tumors Grow (Progressive Disease) You will be randomly assigned to 1 of the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery only to brain tumors that have grown (progressed)</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery to all brain tumors</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06649058' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526#:~:text=Stereotactic%20radiosurgery%20(SRS)%20uses%20many,sense%20because%20there's%20no%20incision.' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li></ul>

67

Stereotactic Radiosurgery for People with Metastatic Breast Cancer with Brain Metastases

Show Scientific Title

EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active Systemic Therapy Options

Nearest Location:
1643 miles
The University of Texas MD Anderson Cancer Center
Houston, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06649058

Phase II

68

Targeted Therapy Avapritinib for Advanced Breast Cancer with a CKIT or PDGFRA Mutation

Show Scientific Title

Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors

Purpose: To study the safety, side effects and anti-cancer activity of the targeted therapy avapritinib (Ayvakit).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer whose tumor tests positive for a CKIT or a PDGFRA mutation. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avapritinib (Ayvakit), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avapritinib (Ayvakit) is an experimental type of targeted therapy called a tyrosine kinase inhibitor. It works by targeting certain CKIT and PDGFRA kinases.</li> <li class="seamTextUnorderedListItem">Avapritinib (Ayvakit) is approved for use in some people with advanced GIST cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers that test positive for CKIT or PDGFRA.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CKIT, PDGFRA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04771520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/avapritinib' target='_blank'>NCI A to Z List of Cancer Drugs: Avapritinib (Ayvakit)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ayvakit.com' target='_blank'>Blueprint Medicines Drug Information Page: Ayvakit (Avapritinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2020/fda-approves-avapritinib-for-pdgfra-mutated-gastrointestinal-stromal-tumor/' target='_blank'>The ASCO Post: FDA Approves Avapritinib for the Treatment of PDGFRA-Mutated Gastrointestinal Stromal Tumor</a> </li></ul>

68

Targeted Therapy Avapritinib for Advanced Breast Cancer with a CKIT or PDGFRA Mutation

Show Scientific Title

Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors

Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04771520

Phase II

69

Targeted Therapy and Chemotherapy for Advanced Triple Negative or Metaplastic HER2 Negative Breast Cancer

Show Scientific Title

Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of alpelisib (Piqray®) PI3K inhibitor, L-NMMA experimental iNOS inhibitor, and nab-paclitaxel (Abraxane®) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or metaplastic HER2 negative (HER2-) breast cancer. You must not have received treatment with everolimus (Afinitor®). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">L-NMMA, by IV, 2 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Aspirin, by mouth, daily</li> <li class="seamTextUnorderedListItem">Amlodipine, by mouth, daily, 1 week on, 2 weeks off</li> <li class="seamTextUnorderedListItem">Metformin, daily</li> <li class="seamTextUnorderedListItem">Cetirizine, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">L-NMMA is an experimental targeted therapy called a iNOS inhibitor which may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Aspirin and amlodipine help prevent deep venous thrombosis (blood clots) and hypertension (high blood pressure).</li> <li class="seamTextUnorderedListItem">Metformin helps prevent hyperglycemia (high blood sugar).</li> <li class="seamTextUnorderedListItem">Cetirizine is an anti-histamine that helps prevents allergic reactions to alpelisib (Piqray®).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05660083' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-015-0527-x' target='_blank'>Journal Article: iNOS Inhibition for Triple Negative Breast Cancer</a> </li></ul>

69

Targeted Therapy and Chemotherapy for Advanced Triple Negative or Metaplastic HER2 Negative Breast Cancer

Show Scientific Title

Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)

Nearest Location:
1643 miles
Houston Methodist Neal Cancer Center
Houston, TX

Visits:
2 visits every 3 weeks

ClinicalTrials.gov: NCT05660083

Phase II

70

Biomarkers to Detect Resistance to Hormone Therapy for Advanced HR+, HER2- Lobular Breast Cancer

Show Scientific Title

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer

Purpose: To identify possible biomarkers of response to hormone therapy for advanced lobular breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) lobular breast cancer (LBC) who are planning to receive hormone therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scans with 18F-FFNP, by IV, 2 times, at baseline and at 1 month</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times, at baseline and at 1 month</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarkers are genes, molecules, or other features present in a person, including in a person’s tumor, that tell doctors something about a person’s health condition.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The tracer used in this study is 18F-FFNP.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy. MRI scans study the blood vessels in the tumor. PET/CT scans study if the tumor cells are growing.</li> <li class="seamTextUnorderedListItem">The blood samples will be used to conduct DNA and circulating tumor cell (CTC) testing.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are cancer cells from a tumor that circulate in the bloodstream.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06067503' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment' target='_blank'>National Cancer Institute: Biomarker Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/pet-scans' target='_blank'>Breastcancer.org: PET Scans</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/ct-scan' target='_blank'>Breastcancer.org: CT Scans</a> </li></ul>

70

Biomarkers to Detect Resistance to Hormone Therapy for Advanced HR+, HER2- Lobular Breast Cancer

Show Scientific Title

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer

Nearest Location:
1678 miles
UW Carbone Cancer Center
Madison, WI

Visits:
2 visits within 1 month

ClinicalTrials.gov: NCT06067503

Phase II

71

Carvedilol and Empagliflozin to Prevent Heart Problems During Treatment for People with Stage I-IV HER2+ Breast Cancer

Show Scientific Title

HER2HEART-US: Primary Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy: a Pilot 2x2 Factorial Randomized Controlled Trial

Purpose: To study the ability of carvedilol (Coreg®) and/or empagliflozin (Jardiance®) heart disease medications to prevent heart problems caused by anti-HER2 targeted therapy.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) HER2 positive (HER2+) breast cancer who are planning to receive anti-HER2 targeted therapy. You must not be planning to receive doxorubicin (Adriamycin®). You must be receiving care at Washington University. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 4 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®), by mouth, daily for 3 months</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Empagliflozin (Jardiance®), by mouth, daily for 3 months</li> </ul> Group 3: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Empagliflozin (Jardiance®), by mouth, daily for 3 months</li> </ul> Group 4: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care (no medication)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some treatments for HER2 positive breast cancer can cause heart problems. No treatments are currently available to prevent these problems.</li> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®) is a heart disease medication called a beta blocker.</li> <li class="seamTextUnorderedListItem">Empagliflozin (Jardiance®) is a heart disease medication called a SGLT2 inhibitor.</li> <li class="seamTextUnorderedListItem">These drugs may help prevent heart problems from cancer treatment.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06844669' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://coreg.com/' target='_blank'>Waylis Therapeutics: Carvedilol (Coreg®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://patient.boehringer-ingelheim.com/us/products/jardiance/heart-failure/benefits?s_kwcid=AL!6545!3!731073183821!b!!g!!jardiance%20reduced%20ejection&cid=cpc:GoogleAds:EA_JAR-HF_DTC_GADS_US_EN_BRAND_GENERIC_TRAFFIC_BMM_g::Jardiance_HFrEF_b_kwd-jardian' target='_blank'>Boehringer Ingelheim: Empagliflozin (Jardiance®)</a> </li></ul>

71

Carvedilol and Empagliflozin to Prevent Heart Problems During Treatment for People with Stage I-IV HER2+ Breast Cancer

Show Scientific Title

HER2HEART-US: Primary Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy: a Pilot 2x2 Factorial Randomized Controlled Trial

Nearest Location:
1739 miles
Washington University School of Medicine
St Louis, MO

Visits:
Coincides with routine care

ClinicalTrials.gov: NCT06844669

Phase II

72

Atezolizumab & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer

Show Scientific Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC)

Purpose: To study the safety and effects (good and bad) of 7 different immunotherapy-based treatment combinations in people with triple negative (ER-/PR-/HER2-) breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer that progressed during or following first-line metastatic treatment with chemotherapy. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 7 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily (2 weeks on, 1 week off), ongoing </li> </ul> Group 7 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Physician's choice chemotherapy (gemcitabine/Gemzar® plus carboplatin/Paraplatin®, or eribulin/Halaven®), by IV, weekly (2 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that works by stimulating the body's immune system to go after cancer cells.</li> <li class="seamTextUnorderedListItem">Tecentriq is approved to treat certain types of urinary, bladder and lung cancer.</li> <li class="seamTextUnorderedListItem">The targeted therapies being used in the study are Ipatasertib (GDC-0068), SGN-LIV1A, bevacizumab (Avastin®) and cobimetinib (Cotellic®).</li> <li class="seamTextUnorderedListItem">The chemotherapies being used in this study are capecitabine (Xeloda®), gemcitabine (Gemzar®), carboplatin (Paraplatin®) and eribulin (Halaven®).</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068) is a type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03424005' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li></ul>

72

Atezolizumab & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer

Show Scientific Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC)

Nearest Location:
1814 miles
The West Clinic
Germantown, TN

Visits:
At least 1 visit every 3 weeks

ClinicalTrials.gov: NCT03424005

Phase I-II

73

Memantine for Cognition with Whole Brain Radiation Therapy for Brain Metastasis

Show Scientific Title

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases

Purpose: To study the effects (good and bad) of memantine and whole brain radiation therapy (WBRT) on your cognition (ability to think).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Memantine (Namenda®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) with pulsed reduced dose rate (PRDR), daily for 10 days</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) is radiation therapy that treats the entire brain.</li> <li class="seamTextUnorderedListItem">WBRT with pulsed reduced dose rate (PRDR) uses a slower rate of radiation to improve safety and anti-cancer activity.</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®) is a medication that treats cognition (ability to think).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05045950' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-77932-377/memantine-oral/memantine-oral/details' target='_blank'>WebMD: Memantine</a> </li></ul>

73

Memantine for Cognition with Whole Brain Radiation Therapy for Brain Metastasis

Show Scientific Title

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases

Nearest Location:
1832 miles
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, WI

Visits:
Daily for 10 days

ClinicalTrials.gov: NCT05045950

Phase II

74

Radiation Therapy and HER2-Targeted Therapies Infused Directly into the Brain for HER2+ Breast Cancer with Leptomeningeal Metastases

Show Scientific Title

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease

Purpose: To study the anti-cancer activity and side effects of giving two anti-HER2 targeted therapies directly into the brain after giving radiation therapy to the brain or spine.

Who is this for?: People with metastatic (stage IV) HER2-positive (HER2+) breast cancer with leptomeningeal disease -- breast cancer that has spread to the leptomeninges (see below for the definition). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy to the brain or spine, 5 to 10 times</li> <li class="seamTextUnorderedListItem">Surgery to place a device (Ommaya reservoir) similar to a chemotherapy port under your scalp</li> <li class="seamTextUnorderedListItem">followed by pertuzumab (Perjeta®) and trastuzumab (Herceptin®), by Ommaya reservoir, twice a week for one month, then once a week for one month, then every two weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery or other times in the treatment process. </li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is a HER2 targeted therapy commonly used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer. </li> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF) -- the fluid or liquid surrounding your brain and spinal cord.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2+ cancer that have spread to the leptomeninges.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04588545' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/cancers/brain-tumor/leptomeningeal-disease/' target='_blank'>Moffitt Cancer Center: Leptomeningeal Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/faq-about-ommaya-reservoirs-and-ommaya-taps' target='_blank'>Memorial Sloan Kettering Cancer Center: Frequently Asked Questions About Ommaya Reservoirs and Ommaya Taps</a> </li></ul>

74

Radiation Therapy and HER2-Targeted Therapies Infused Directly into the Brain for HER2+ Breast Cancer with Leptomeningeal Metastases

Show Scientific Title

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease

Nearest Location:
1851 miles
Northwestern University
Evanston, IL

Visits:
Approximately 22 visits over the first 2.5 months; then 1 visit every 2 weeks, ongoing

ClinicalTrials.gov: NCT04588545

Phase I-II

75

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

Show Scientific Title

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC)

Purpose: To determine the safety and effects (good and bad) of treating HER2-negative metastatic breast cancer with an immunotherapy drug along with a chemotherapy drug.

Who is this for?: People with metastatic (stage IV) breast cancer that is HER2 negative. If you are estrogen receptor positive, you must have progressed on available endocrine therapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for up to 2 years</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 2 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">The chemotherapy drug is carboplatin (Paraplatin®). It is used to treat metastatic breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03213041' target='_blank'>ClinicalTrials.gov</a> </li></ul>

75

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

Show Scientific Title

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC)

Nearest Location:
1856 miles
Northwestern University
Chicago, IL

Visits:
1 visit every 3 weeks, ongoing

ClinicalTrials.gov: NCT03213041

Phase II

76

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Show Scientific Title

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor, stereotactic radiosurgery, chemotherapy, and durvalumab (Imfinzi®) PD-L1 inhibitor.

Who is this for?: Postmenopausal women or men with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis). If you have HER2- breast cancer, you must also have a germline (inherited) or somatic (tumor) BRCA mutation. You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS), 1-5 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®)</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®) are chemotherapy drugs that slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711824' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html' target='_blank'>MedlinePlus: Durvalumab (Imfinzi®)</a> </li></ul>

76

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Show Scientific Title

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

Nearest Location:
1946 miles
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, IN

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04711824

Phase I-II

77

ctDNA Tests to Support Treatment Decisions for People with Metastatic Triple Negative, PD-L1 Negative Breast Cancer

Show Scientific Title

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To study how well circulating tumor DNA (ctDNA) tests work to support decisions to change treatment.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-), PD-L1 negative breast cancer who have not received chemotherapy for metastatic disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Blood samples for ctDNA tests</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan, 2 times</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Blood samples for ctDNA tests</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan, 2 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to sacituzumab govitecan (Trodelvy®), by IV (depending on blood test results)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">Studying ctDNA may help your doctor decide to change your treatment earlier (if needed) and may improve your health outcomes.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05770531' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/ctdna-mbc/' target='_blank'>Metastatic Trial Talk: The Latest Research on ctDNA and MBC</a> </li></ul>

77

ctDNA Tests to Support Treatment Decisions for People with Metastatic Triple Negative, PD-L1 Negative Breast Cancer

Show Scientific Title

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer

Nearest Location:
1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville, TN

Visits:
Coincides with routine care

ClinicalTrials.gov: NCT05770531

Phase II

78

Sacituzumab Govitecan ADC and Trastuzumab Targeted Therapy for Advanced HER2+ Breast Cancer

Show Scientific Title

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After progrEssion on ENhertu (SATEEN)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (Enhertu®, T-DXd) antibody drug conjugate (ADC) with trastuzumab (Herceptin®) anti-HER2 targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with trastuzumab (Herceptin®), trastuzumab deruxtecan (Enhertu®), and paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), or docetaxel (Taxotere®). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd), weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT or MRI scans, every 2-3 months</li> <li class="seamTextUnorderedListItem">Heart scan, every 3-4 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Herceptin® Hylecta is a form of trastuzumab that is given by injection instead of by IV.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06100874' target='_blank'>ClinicalTrials.gov</a> </li></ul>

78

Sacituzumab Govitecan ADC and Trastuzumab Targeted Therapy for Advanced HER2+ Breast Cancer

Show Scientific Title

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After progrEssion on ENhertu (SATEEN)

Nearest Location:
1959 miles
SCRI Oncology Partners
Nashville, TN

Visits:
1 visit every 1-2 weeks

ClinicalTrials.gov: NCT06100874

Phase II

79

Palliative Radiation and Immunotherapy for People with Metastatic Breast Cancer

Show Scientific Title

A Phase 2 Study of Palliative Radiation in Combination With Pembrolizumab in Subjects With Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of stereotactic radiation with pembrolizumab (Keytruda®) immunotherapy.

Who is this for?: Women with stage IV (metastatic) breast cancer who have received at least 2 lines of therapy, including 1 line of chemotherapy. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation, 1-5 sessions</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Palliative radiation reduces side effects of metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04990921' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncolink.org/support/hospice-and-palliative-care/palliative-radiation-treatment#:~:text=Palliative%20radiation%20is%20the%20use,doses)%20than%20traditional%20radiation%20treatment.' target='_blank'>OncoLink: Palliative Radiation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

79

Palliative Radiation and Immunotherapy for People with Metastatic Breast Cancer

Show Scientific Title

A Phase 2 Study of Palliative Radiation in Combination With Pembrolizumab in Subjects With Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink

Nearest Location:
1984 miles
James Graham Brown Cancer Center
Louisville, KY

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT04990921

Phase II

80

PET/MRI Scans with FDG to Monitor Response to Treatment for Metastatic HER2+ Breast Cancer

Show Scientific Title

Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)

Purpose: To study if PET/MRI scans with FDG can monitor your response to treatment.

Who is this for?: Women with metastatic (stage IV) HER2 positive (HER2+) breast cancer who are planning to receive their first anti-HER2 targeted therapy for metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">18F-Fluorodeoxyglucose (FDG), by injection, 3 times within 6 months</li> <li class="seamTextUnorderedListItem">PET/MRI scans, 3 times within 6 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">FDG is a tracer with a radioactive tag that is used to visualize cancer cells.</li> <li class="seamTextUnorderedListItem">PET/MRI scanning is a new imaging technique that combines PET and MRI scans into a single scan.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04273555' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/programs/imaging-center/exams/nuclear-medicine/pet-mri.html' target='_blank'>Cedars-Sinai: PET/MRI Scan</a> </li></ul>

80

PET/MRI Scans with FDG to Monitor Response to Treatment for Metastatic HER2+ Breast Cancer

Show Scientific Title

Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)

Nearest Location:
2013 miles
The University of Alabama at Birmingham
Birmingham, AL

Visits:
3 visits within 6 months

ClinicalTrials.gov: NCT04273555

Phase I-II

81

Tango Dance Lessons to Reduce Nerve Pain for People with Stage I-IV Breast Cancer

Show Scientific Title

DANCE-BASED AVENUES to ADVANCE NONPHARMACOLOGIC TREATMENT of CHEMOTHERAPY EFFECTS (DAANCE): a MULTICENTER TRIAL

Purpose: To study if tango dance lessons can reduce nerve pain caused by chemotherapy.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who completed treatment with paclitaxel (Taxol®) or docetaxel (Taxotere®) chemotherapy at least 3 months ago. You must have nerve pain (neuropathy). View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tango dance lessons, 2 times every week for 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times in 3 months</li> <li class="seamTextUnorderedListItem">Body function tests, 3 times in 3 months</li> </ul> Group 2: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care, 1 month</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times in 3 months</li> <li class="seamTextUnorderedListItem">Body function tests, 3 times in 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tango dance lessons, 2 times every week for 2 months (optional)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Up to 80% of people with cancer who receive some chemotherapy drugs called taxanes experience neuropathy.</li> <li class="seamTextUnorderedListItem">Neuropathy is pain in your hands and feet from nerve damage as a side effect of chemotherapy.</li> <li class="seamTextUnorderedListItem">Neuropathy decreases quality of life and increases the risk of falling. Treatment options are limited.</li> <li class="seamTextUnorderedListItem">Taxanes are paclitaxel (Taxol®) and docetaxel (Taxotere®).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06749210' target='_blank'>ClinicalTrials.gov</a> </li></ul>

81

Tango Dance Lessons to Reduce Nerve Pain for People with Stage I-IV Breast Cancer

Show Scientific Title

DANCE-BASED AVENUES to ADVANCE NONPHARMACOLOGIC TREATMENT of CHEMOTHERAPY EFFECTS (DAANCE): a MULTICENTER TRIAL

Nearest Location:
2105 miles
The Ohio State University
Columbus, OH

Visits:
2 visits every week for 2 months

ClinicalTrials.gov: NCT06749210

Phase II

82

Stereotactic Radiation, Abemaciclib, and Hormone Therapy for HR+, HER2- Breast Cancer Brain Metastases

Show Scientific Title

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Purpose: To study the anti-cancer activity and side effects of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®), hormone therapy, and stereotactic radiation therapy together to treat brain metastases.

Who is this for?: People with metastatic (stage IV) hormone receptor-positive, HER2 negative (HER2-) breast cancer that has spread to the brain. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Doctor's choice of anti-estrogen therapy, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiation Therapy to each brain met</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. This stops cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Anti-estrogen therapies are commonly used to treat hormone receptor-positive breast cancer. These drugs are also called endocrine or hormone therapy and include tamoxifen, aromatase inhibitors, fulvestrant, and others. </li> <li class="seamTextUnorderedListItem">The hormone therapies used in this trial are fulvestrant and aromatase inhibitors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04923542' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/?s=brain+mets' target='_blank'>Metastatic Trial Talk: Topics for Breast Cancer Brain Mets</a> </li></ul>

82

Stereotactic Radiation, Abemaciclib, and Hormone Therapy for HR+, HER2- Breast Cancer Brain Metastases

Show Scientific Title

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Nearest Location:
2108 miles
Ohio State University Comprehensive Cancer Center
Columbus, OH

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04923542

Phase I-II

83

Stereotactic Radiosurgery Before Brain Surgery for Brain Metastasis

Show Scientific Title

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Purpose: To study the safety, effects (good and bad), best dose, and anti-cancer activity of stereotactic radiosurgery given before brain surgery.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) and 1-4 brain tumors. You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01891318' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

83

Stereotactic Radiosurgery Before Brain Surgery for Brain Metastasis

Show Scientific Title

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Nearest Location:
2193 miles
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, OH

Visits:
May require hospitalization

ClinicalTrials.gov: NCT01891318

Phase I-II

84

Patritumab Deruxtecan Antibody Drug Conjugate with Anti-HER2 Targeted Therapy for Advanced HER2+ Breast Cancer

Show Scientific Title

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of patritumab deruxtecan (MK-1022), an experimental antibody drug conjugate (ADC), with other anti-HER2 targeted therapies.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. You must not have received more than 5 previous lines of anti-HER2 targeted therapy. You must not have leptomeningeal metastases (leptomeningeal disease). View full eligibility criteria

What's involved?

You will be assigned to 1 of 3 groups based on your treatment history: Group 1: Recieved T-DXd and 2-5 Lines of Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> </ul> Group 2: Received up to 5 Lines of Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta), by IV, every 3 weeks</li> </ul> Group 3: Received T-DXd and up to 3 Lines of Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan is an experimental HER3-targeted antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells. </li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Patritumab deruxtecan's antibody targets HER3 and delivers an anti-cancer drug.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are anti-HER2 targeted therapies commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06686394' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update on Antibody-Drug Conjugates (ADCs) for MBC</a> </li></ul>

84

Patritumab Deruxtecan Antibody Drug Conjugate with Anti-HER2 Targeted Therapy for Advanced HER2+ Breast Cancer

Show Scientific Title

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Nearest Location:
2223 miles
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)
Greenville, SC

Visits:
1 visit every 3 weeks

ClinicalTrials.gov: NCT06686394

Phase I-II

85

Propranolol and Pembrolizumab for Women with Advanced Triple Negative Breast Cancer

Show Scientific Title

Impact of Beta-2 Adrenergic Blockade With Checkpoint Inhibition in Checkpoint Inhibitor Refractory Metastatic Triple Negative Breast Cancer

Purpose: To study if propranolol, a high blood pressure drug, can improve the anti-cancer activity of pembrolizumab (Keytruda®), a PD-1 inhibitor.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received chemotherapy with pembrolizumab (Keytruda®) for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Propranolol, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">Questionaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Propranolol is a beta blocker drug used to treat high blood pressure and heart problems.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Beta blockers, including propranolol, may reduce the effects of some stress hormones produced by the body during cancer treatment. This process may help pembrolizumab (Keytruda®) work better.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05741164' target='_blank'>ClinicalTrials.gov</a> </li></ul>

85

Propranolol and Pembrolizumab for Women with Advanced Triple Negative Breast Cancer

Show Scientific Title

Impact of Beta-2 Adrenergic Blockade With Checkpoint Inhibition in Checkpoint Inhibitor Refractory Metastatic Triple Negative Breast Cancer

Nearest Location:
2299 miles
Roswell Park Cancer Institute
Buffalo, NY

Visits:
About 1 visit every 3 weeks

ClinicalTrials.gov: NCT05741164

Phase II

86

Methotrexate in Metastatic Breast Cancer With Leptomeningeal Metastasis

Show Scientific Title

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail

Purpose: To study the effects (good and bad) of using high-dose methotrexate to treat metastases in the cerebrospinal fluid surrounding the brain and spinal cord and/or in the leptomeninges (the lining of the brain and spinal cord).

Who is this for?: People with metastatic (stage IV) breast cancer with leptomeningeal metastases (defined below). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">High-dose Methotrexate (HD-MTX), by IV, once every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">Methotrexate is a chemotherapy approved to treat advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Researchers believe methotrexate can cross the blood-brain barrier, which will allow the drug to reach the leptomeningeal metastases.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02422641' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/cancerwise/2017/04/new-hope-for-leptomeningeal-disease-care.html' target='_blank'>MDAnderson: New Hope for Leptomeningeal Disease Care</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li></ul>

86

Methotrexate in Metastatic Breast Cancer With Leptomeningeal Metastasis

Show Scientific Title

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail

Nearest Location:
2314 miles
Comprehensive Cancer Center at Wake Forest University (CCCWFU)
Winston-Salem, NC

Visits:
1 visit every 2 weeks, ongoing

ClinicalTrials.gov: NCT02422641

Phase II

87

Neratinib Targeted Therapy with Capecitabine Chemotherapy for Metastatic HER2 Negative Breast Cancer with Abnormally Active HER2 Signaling and Brain Metastases

Show Scientific Title

An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) anti-HER2 targeted therapy with capecitabine (Xeloda®) chemotherapy.

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with abnormally active HER2 signaling that has spread to the brain (brain metastasis). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 day off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an oral drug approved by the U.S. Food and Drug Administration (FDA) to treat HER2 positive breast cancer. It is considered investigational in this study because your breast cancer was determined to be HER2 negative by the standard method of testing. However, the CELsignia test showed that your breast cancer cells have HER2 pathway activity that might respond to HER2-targeted treatment.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug that may slow or stop breast cancer cells from growing.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04965064' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>

87

Neratinib Targeted Therapy with Capecitabine Chemotherapy for Metastatic HER2 Negative Breast Cancer with Abnormally Active HER2 Signaling and Brain Metastases

Show Scientific Title

An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

Nearest Location:
2352 miles
University of Rochester
Rochester, NY

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04965064

Phase II

88

Personalized Vaccine with Pembrolizumab for Advanced Breast Cancer

Show Scientific Title

A Phase I Pilot Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of a personalized neoantigen peptide vaccine, an experimental type of immunotherapy, with pembrolizumab (Keytruda®), a type of immunotherapy called a PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer that have received at least 1 line of standard treatment. If you have triple negative (ER-, PR-, HER2-) breast cancer, you must currently be receiving treatment with pembrolizumab (Keytruda®). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 session</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccine, by injection, 4 times in 2 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Sargramostim, by injection, 4 times in 2 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require at least 1 biopsy</li> <li class="seamTextUnorderedListItem">May require 1 additional vaccine</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The neoantigen peptide vaccine will be personalized to your cancer based on your blood and biopsy results.</li> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccines are an experimental type of immunotherapy.</li> <li class="seamTextUnorderedListItem">The vaccine is designed to target certain proteins (neoantigens) on tumor cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Before you receive the vaccine, you will be given the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your immune system to receive the vaccine.</li> <li class="seamTextUnorderedListItem">Sargramostim is a type of immunotherapy that stimulates your body to produce more immune cells to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05269381' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20529594?_ga=2.9537585.506318734.1653082699-1752475516.1651774270' target='_blank'>Mayo Clinic: Clinical Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/drugs/20884-sargramostim-gm-csf-injection' target='_blank'>Cleveland Clinic: Sargramostim</a> </li></ul>

88

Personalized Vaccine with Pembrolizumab for Advanced Breast Cancer

Show Scientific Title

A Phase I Pilot Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

Nearest Location:
2383 miles
Mayo Clinic in Florida
Jacksonville, FL

Visits:
5 visits in 3 weeks, then 1 visit every 3 weeks

ClinicalTrials.gov: NCT05269381

Phase I-II

89

ADC, Targeted Therapy, and Stereotactic Radiation for Metastatic Triple Negative Breast Cancer with Brain Metastases

Show Scientific Title

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of stereotactic radiation, sacituzumab govitecan (Trodelvy®) antibody drug conjugate, and zimberelimab experimental targeted therapy.

Who is this for?: People with metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer that has spread to the brain (brain metastasis) and who have at least 1 brain lesion that has not been treated with radiation. You must have received chemotherapy with doxorubicin (Adriamycin®) and at least 1 of the following: paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), or docetaxel (Taxotere®). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation</li> </ul> followed 1 week later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Zimberelimab, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Zimberelimab is an experimental targeted therapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06238921' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/zimberelimab' target='_blank'>National Cancer Institute: Zimberelimab</a> </li></ul>

89

ADC, Targeted Therapy, and Stereotactic Radiation for Metastatic Triple Negative Breast Cancer with Brain Metastases

Show Scientific Title

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Nearest Location:
2395 miles
Moffitt Cancer Center
Tampa, FL

Visits:
At least 1 visit every 1-2 weeks

ClinicalTrials.gov: NCT06238921

Phase I-II

90

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

Show Scientific Title

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers

Purpose: To study the safety and effects (good and bad) of using a new type of CAR T-cell immunotherapy.

Who is this for?: People with metastatic (stage IV) breast cancer that tests positive for CD70 who have already received at least one standard therapy. View full eligibility criteria

What's involved?

You will receive the following: Hospital stay (at least 1-week): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide, by IV, once a day, for 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine, by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 3 times a day, for 3 days</li> <li class="seamTextUnorderedListItem">Anti-hCD70 CAR T-cells, by IV, one time</li> </ul> Post-hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic for 6 months</li> <li class="seamTextUnorderedListItem">Repeat Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">1-2 day hospital visits (for lab tests, imaging studies, and a physical exam), every 1-3 months for the 1st year after treatment, every 6 months for the 2nd year, and then as determined by your doctor</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">After your blood cells are removed, they are modified with chimeric antigen receptors (CARs) so they can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study is designed to get the immune system to see and kill cancer cells that are CD70+. </li> <li class="seamTextUnorderedListItem">Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph cells. </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CD70</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02830724' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr Susan Love Research Foundation: CAR-T Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/25368676' target='_blank'>Journal Article Abstract: CD70, A Potential Target in Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search?contains=false&q=Aldesleukin' target='_blank'>NCI Drug Dictionary: Aldesleukin</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

90

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

Show Scientific Title

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers

Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

Visits:
Hospital stay for at least 1 week; follow-up visits for 2 years

ClinicalTrials.gov: NCT02830724

Phase I-II

91

Stereotactic Radiation & Standard of Care for Metastatic Breast Cancer with 1 to 5 Metastases (Oligometastatic Disease)

Show Scientific Title

A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer

Purpose: To compare the effects (good and bad) of using stereotactic body radiotherapy (SBRT) along with a standard of care to just the standard of care.

Who is this for?: People with metastatic (stage IV) breast cancer with only one to five metastases (oligometastatic disease). View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic Body Radiotherapy (SBRT)</li> <li class="seamTextUnorderedListItem">Standard of care determined by your physician</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care determined by your physician</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oligometastatic breast cancer is metastatic breast cancer with a small number of metastases.</li> <li class="seamTextUnorderedListItem">SBRT can be used to deliver precise, intense doses of radiation to specific places where cancer has spread. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of oligometastatic cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03808337' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.uclahealth.org/radonc/faqs-sbrt' target='_blank'>UCLA Health: SBRT FAQs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/radiotherapy/external/types/stereotactic-body-radiotherapy-sbrt' target='_blank'>CancerResearchUK: Stereotactic Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oligometastatic-breast-cancer/' target='_blank'>Metastatic Trial Talk: What is Oligometastatic Breast Cancer?</a> </li></ul>

91

Stereotactic Radiation & Standard of Care for Metastatic Breast Cancer with 1 to 5 Metastases (Oligometastatic Disease)

Show Scientific Title

A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer

Nearest Location:
2494 miles
Lehigh Valley Health Network
Allentown, PA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT03808337

Phase II

92

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer

Show Scientific Title

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor, pembrolizumab (Keytruda®) PD-1 inhibitor, and fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) breast cancer who have received hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received more than 2 lines of chemotherapy for advanced disease or a PD-1/PD-L1 inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by IV, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06110793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

92

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer

Show Scientific Title

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer

Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

Visits:
1 visit every month

ClinicalTrials.gov: NCT06110793

Phase I-II

93

Tucatinib Before Surgery for Metastatic HER2+ Breast Cancer That Has Spread to the Brain

Show Scientific Title

Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance

Purpose: To study how the brain absorbs, distributes, and gets rid of tucatinib (Tukysa®) in people who have HER2+ breast cancer that has spread to the brain, and to learn more about how cancer cells develop resistance to treatment.

Who is this for?: Women with metastatic (stage IV) HER2+ breast cancer that has spread to the brain (brain metastases) and who are planning to receive surgery to remove the cancer. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 5 days</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a type of HER2 targeting therapy called a kinase inhibitor. It is able to cross the blood-brain barrier. This means it works against cancer cells that have spread to the brain. Tucatinib is approved for use in people with metastatic, HER2+ breast cancer when it is taken with trastuzumab and capecitabine. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05892068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib</a> </li></ul>

93

Tucatinib Before Surgery for Metastatic HER2+ Breast Cancer That Has Spread to the Brain

Show Scientific Title

Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance

Nearest Location:
2539 miles
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)
Basking Ridge, NJ

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05892068

Phase II

94

Radiation During Surgery for Recurrent Brain Metastases

Show Scientific Title

Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Purpose: To compare the safety, anti-cancer activity, and side effects of brachytherapy (a type of radiation that occurs during brain surgery) with the usual approach of brain surgery without brachytherapy.

Who is this for?: People with metastatic (stage IV) breast cancer with brain metastases (cancer that has spread to the brain) that has already been treated with radiation. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery </li> <li class="seamTextUnorderedListItem">Cesium 131 (Cs131) brachytherapy (radiation), during surgery</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brachytherapy is a type of internal radiation therapy. It works by placing a radioactive material directly inside or next to the tumor. </li> <li class="seamTextUnorderedListItem">It takes less time than traditional radiation and uses a higher total radiation dose to treat a smaller area.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04690348' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/radiation-therapy/brachytherapy#:~:text=Brachytherapy%20is%20a%20type%20of%20internal%20radiation%20therapy%20in%20which,specific%20part%20of%20your%20body.' target='_blank'>Cancer.gov: Brachytherapy</a> </li></ul>

94

Radiation During Surgery for Recurrent Brain Metastases

Show Scientific Title

Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Nearest Location:
2539 miles
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, NJ

Visits:
Coincides with surgery

ClinicalTrials.gov: NCT04690348

Phase II

95

Stereotactic Body Radiation Therapy for Metastatic HER2+, HER2 Low, or ER+, HER2- Breast Cancer

Show Scientific Title

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of stereotactic body radiotherapy (SBRT).

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+), HER2 low, or estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. You must have a small number of metastases (oligometastatic disease) and have received standard treatment. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic body radiotherapy (SBRT), 3-5 sessions</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oligometastatic breast cancer is metastatic breast cancer with a small number of metastases.</li> <li class="seamTextUnorderedListItem">Stereotactic body radiotherapy (SBRT) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">During this trial, you will continue your current line of therapy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05534438' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.uclahealth.org/departments/radonc/research-technologies/innovation-technology/external-beam-radiation-therapy-ebrt/stereotactic-body-radiation-therapy-sbrt/faqs-sbrt' target='_blank'>UCLA Health: Stereotactic Body Radiation Therapy (SBRT)</a> </li></ul>

95

Stereotactic Body Radiation Therapy for Metastatic HER2+, HER2 Low, or ER+, HER2- Breast Cancer

Show Scientific Title

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

Nearest Location:
2561 miles
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, NJ

Visits:
3-5 visits within 1 week

ClinicalTrials.gov: NCT05534438

Phase II

96

Pembrolizumab (Immunotherapy) And Radiosurgery (Radiation) to Treat Brain Metastases

Show Scientific Title

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Purpose: To study the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with stereotactic radiosurgery (SRS) to treat breast cancer that has spread to the brain.

Who is this for?: Women with metastatic (stage IV) breast cancer and at least two brain metastases. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS), once after the first treatment of pembrolizumab</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">It stimulates the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain types of cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery is not surgery. It is a type of radiation therapy that precisely targets metastases in the brain.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03449238' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/local/brain/radiosurgery' target='_blank'>Breastcancer.org: Stereotactic Radiosurgery for Brain Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li></ul>

96

Pembrolizumab (Immunotherapy) And Radiosurgery (Radiation) to Treat Brain Metastases

Show Scientific Title

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Nearest Location:
2567 miles
Weill Cornell Medicine
New York, NY

Visits:
1 visit every 3 weeks, ongoing

ClinicalTrials.gov: NCT03449238

Phase I-II

97

Trastuzumab Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases

Show Scientific Title

Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT)

Purpose: To study the safety, effects, and anti-cancer activity of trastuzumab deruxtecan (T-DXd, Enhertu®) antibody-drug conjugate (ADC) for people with brain metastases.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 mutated breast cancer that has spread to the brain (brain metastasis) and are planning to receive brain surgery. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06058988' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (T-DXd, Enhertu®)</a> </li></ul>

97

Trastuzumab Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases

Show Scientific Title

Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT)

Nearest Location:
2567 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, NY

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06058988

Phase II

98

Abemaciclib With Bicalutamide for Androgen Receptor+, HER2- Advanced Breast Cancer

Show Scientific Title

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Purpose: To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®) together with bicalutamide (Casodex®), an anti-androgen drug.

Who is this for?: Postmenopausal women with advanced (some stage III) or metastatic (stage IV) androgen receptor positive (AR+) HER2 negative breast cancer. You must have received at least one line of therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®), by mouth, twice daily</li> </ul> Please contact research site for treatment schedule.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05095207' target='_blank'>ClinicalTrials.gov</a> </li></ul>

98

Abemaciclib With Bicalutamide for Androgen Receptor+, HER2- Advanced Breast Cancer

Show Scientific Title

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Nearest Location:
2568 miles
Mount Sinai - West
New York, NY

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05095207

Phase I-II

99

Sacituzumab Govitecan ADC After T-DXd ADC for Advanced HR+, HER2 Low Breast Cancer

Show Scientific Title

SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW MetaStatic Breast Cancer

Purpose: To study if sacituzumab govitecan (SG, Trodelvy®) is still effective at the currently approved dose and schedule for people with advanced HR+, HER2 low breast cancer who have already received trastuzumab deruxtecan (T-DXd, Enhertu®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 low breast cancer who have received treatment with hormone therapy, CDK4/6 inhibitor, trastuzumab deruxtecan (T-DXd, Enhertu®), and 1-4 lines of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (SG, Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Although Sacituzumab govitecan (SG, Trodelvy®) is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if it is still effective specifically in people who have already received T-DXd.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (SG, Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (SG, Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+/ISH- or IHC 1+/ISH- or ISH untested.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06263543' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (SG, Trodelvy®)</a> </li></ul>

99

Sacituzumab Govitecan ADC After T-DXd ADC for Advanced HR+, HER2 Low Breast Cancer

Show Scientific Title

SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW MetaStatic Breast Cancer

Nearest Location:
2587 miles
Miami Cancer Institute at Baptist Health, Inc.
Miami, FL

Visits:
1 visit every 1-2 weeks

ClinicalTrials.gov: NCT06263543

Phase II

100

Azeliragon and Stereotactic Radiation for Breast Cancer with Brain Metastases

Show Scientific Title

A Phase I/II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases (ADORATION)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of azeliragon, an experimental anti-cancer therapy, with stereotactic radiosurgery.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have at least 1 lesion that has not received radiation. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily, up to 2 years</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon is an experimental anti-cancer drug. It is also being studied for treating Alzheimer's and glioblastoma, a type of brain cancer.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05789589' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fda-grants-orphan-drug-designation-to-azeliragon-for-gbm' target='_blank'>OncLive: Azeliragon for Glioblastoma</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/stereotactic-radiosurgery#:~:text=What%20is%20stereotactic%20radiosurgery%3F,trigeminal%20neuralgia%20and%20arteriovenous%20malformations.' target='_blank'>Johns Hopkins Medicine: Stereotactic Radiosurgery</a> </li></ul>

100

Azeliragon and Stereotactic Radiation for Breast Cancer with Brain Metastases

Show Scientific Title

A Phase I/II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases (ADORATION)

Nearest Location:
2587 miles
Miami Cancer Institute at Baptist Health, Inc.
Miami, FL

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05789589

Phase I-II

101

Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of hormone therapy and targeted therapy based on biomarker testing.

Who is this for?: Post-menopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) or HER2 low breast cancer. You must have received treatment with palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) for advanced disease. View full eligibility criteria

What's involved?

You will be assigned to 1 of 4 groups based on biomarker testing results: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive treatment based on ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1 biomarker testing results.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05933395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>

101

Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)

Nearest Location:
2619 miles
Dartmouth Hitchcock Medical Center
Lebanon, NH

Visits:
1 visit every month

ClinicalTrials.gov: NCT05933395

Phase II

102

Stereotactic Radiation with AGuIX® for Brain Metastases

Show Scientific Title

A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone

Purpose: To determine if AGuIX® (Activation and Guidance of Irradiation by X-ray) can make stereotactic radiation work more effectively.

Who is this for?: People with metastatic (stage IV) breast cancer whose cancer has spread to their brain (brain metastases). View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AGuIX®, by IV, 3-5 days before radiation and up to 2 additional sessions during radiation sessions</li> <li class="seamTextUnorderedListItem">Stereotactic radiation, up to 6 sessions</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for AGuIX®, by IV, 3-5 days before radiation and up to 2 additional sessions during radiation sessions</li> <li class="seamTextUnorderedListItem">Stereotactic radiation, up to 6 sessions</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AGuIX® is short for Activation and Guidance of Irradiation by X-ray.</li> <li class="seamTextUnorderedListItem">AGuIX® consists of two parts: a drug that helps improve visualization of MRI scans and a drug that may make stereotactic radiation work more effectively.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04899908' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://nhtheraguix.com/aguix/' target='_blank'>NH TherAguix Information Page: AGuIX®</a> </li></ul>

102

Stereotactic Radiation with AGuIX® for Brain Metastases

Show Scientific Title

A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone

Nearest Location:
2693 miles
Dana Farber Cancer Institute
Boston, MA

Visits:
7 visits

ClinicalTrials.gov: NCT04899908

Phase II

103

Scalp Cooling to Prevent Hair Loss During Chemotherapy for People With Metastatic Breast Cancer

Show Scientific Title

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Purpose: To study the ability of the Paxman Scalp Cooling System to prevent hair loss during treatment with chemotherapy.

Who is this for?: People with metastatic (stage IV) breast cancer that are planning to receive chemotherapy. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups: Group 1: Chemotherapy with Scalp Cooling <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paxman Scalp Cooling System, every 3 weeks</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or trastuzumab deruxtecan (Enhertu®), by IV, every 1-3 weeks</li> </ul> Group 2: Chemotherapy without Scalp Cooling <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or trastuzumab deruxtecan (Enhertu®), by IV, every 1-3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Paxman Scalp Cooling System is FDA-approved for preventing hair loss for people undergoing chemotherapy.</li> <li class="seamTextUnorderedListItem">The Paxman Scalp Cooling System has not been studied to look at its ability to prevent hair loss in patients specifically receiving eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or trastuzumab deruxtecan (Enhertu®).</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a HER2-targeted antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a Trop-2-targeted antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04986579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://coldcap.com//?lang=us' target='_blank'>Paxman: Paxman Scalp Cooling System</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/managing-hair-loss-scalp-cooling' target='_blank'>Memorial Sloan Kettering Cancer Center: Scalp Cooling</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (Enhertu®)</a> </li></ul>

103

Scalp Cooling to Prevent Hair Loss During Chemotherapy for People With Metastatic Breast Cancer

Show Scientific Title

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Nearest Location:
2693 miles
Brigham and Women's Hospital
Boston, MA

Visits:
1 visit every 1-3 weeks

ClinicalTrials.gov: NCT04986579

Phase II

104

VS-6766 Targeted Therapy for Advanced HR+, HER2- Breast Cancer

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A Single Arm Phase 1/2 Trial of Abemaciclib + VS-6766 + Fulvestrant in Metastatic HR+/HER2- Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of VS-6766, an experimental RAF/MEK inhibitor, with abemaciclib (Verzenio®) CDK 4/6 inhibitor and fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must have received treatment with fulvestrant (Faslodex)® for advanced/metastatic disease and a CDK 4/6 inhibitor after surgery (adjuvant) or for advanced/metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766 is an experimental targeted therapy called a RAF/MEK inhibitor that targets and interrupts a pathway that allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05608252' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verastem.com/research/pipeline/#raf-mek-inhibition' target='_blank'>Verastem: VS-6766 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

104

VS-6766 Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A Single Arm Phase 1/2 Trial of Abemaciclib + VS-6766 + Fulvestrant in Metastatic HR+/HER2- Breast Cancer

Nearest Location:
2693 miles
Dana Farber Cancer Institite
Boston, MA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05608252

Phase I-II

105

Multiple Anti-HER2 Targeted Therapies for de Novo Metastatic HER2+ Breast Cancer

Show Scientific Title

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of multiple anti-HER2 targeted therapies in a row instead of changing treatment after cancer progresses.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who were diagnosed with breast cancer at stage IV (de novo). You must not have received treatment except for less than 1.5 months of trastuzumab (Herceptin®), pertuzumab (Perjeta®), and chemotherapy (THP). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), docetaxel (Taxotere®), or nab-paclitaxel (Abraxane®), by IV, every 1-3 weeks for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks for 4-5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by IV, every 3 weeks for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 1 year</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 1 year</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The U.S. Food and Drug Administration (FDA) has approved all the study drugs as a treatment option for metastatic HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">In standard of care treatment, you typically change treatment after your cancer progresses.</li> <li class="seamTextUnorderedListItem">In this study, you will receive a series of treatments in a row without waiting for disease progression.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are anti-HER2 targeted therapies used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), docetaxel (Taxotere®), or nab-paclitaxel (Abraxane®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd) and trastuzumab emtansine (Kadcyla®, T-DM1) are antibody drug conjugates (ADCs).</li> <li class="seamTextUnorderedListItem">An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme that helps cancer cells grow.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06439693' target='_blank'>ClinicalTrials.gov</a> </li></ul>

105

Multiple Anti-HER2 Targeted Therapies for de Novo Metastatic HER2+ Breast Cancer

Show Scientific Title

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study

Nearest Location:
2693 miles
Dana-Farber Cancer Institute
Boston, MA

Visits:
1 visit every 1-3 weeks for 1.5 years

ClinicalTrials.gov: NCT06439693

Phase II

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Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Advanced Breast Cancer

Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Advanced Breast Cancer

Alisertib Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Alisertib Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

177Lu-FAP-2286 Radioactive Drug for Advanced Breast Cancer

177Lu-FAP-2286 Radioactive Drug for Advanced Breast Cancer

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or ER Low Breast Cancer

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or ER Low Breast Cancer

ETX-636 Targeted Therapy for Advanced HR+, HER2- Breast Cancer With PIK3CA Mutations

ETX-636 Targeted Therapy for Advanced HR+, HER2- Breast Cancer With PIK3CA Mutations

ORIC-114 Targeted Therapy for Advanced HER2+ Breast Cancer

ORIC-114 Targeted Therapy for Advanced HER2+ Breast Cancer

BNT327 with Chemotherapy for Advanced Triple Negative Breast Cancer

BNT327 with Chemotherapy for Advanced Triple Negative Breast Cancer

eFT226 in Advanced Breast Cancer That Tests Positive for HER2, ERBB3, FGFR1, FGFR2, or KRAS Mutations

eFT226 in Advanced Breast Cancer That Tests Positive for HER2, ERBB3, FGFR1, FGFR2, or KRAS Mutations

PRO1184 Antibody Drug Conjugate for Advanced HER2- Breast Cancer that Expresses FRA

PRO1184 Antibody Drug Conjugate for Advanced HER2- Breast Cancer that Expresses FRA

AZD8205 for Advanced Triple Negative BreastCancer

AZD8205 for Advanced Triple Negative BreastCancer

Belzutifan Targeted Therapy with Hormone Therapy for Advanced ER+, HER2- Breast Cancer

Belzutifan Targeted Therapy with Hormone Therapy for Advanced ER+, HER2- Breast Cancer

Eniluracil Targeted Therapy with Chemotherapy for Advanced HER2- Breast Cancer

Eniluracil Targeted Therapy with Chemotherapy for Advanced HER2- Breast Cancer

Utidelone Chemotherapy for Metastatic HER2- or HER2 Low Breast Cancer with Brain Metastases

Utidelone Chemotherapy for Metastatic HER2- or HER2 Low Breast Cancer with Brain Metastases

Invikafusp Alfa Immunotherapy with ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

Invikafusp Alfa Immunotherapy with ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

PMD-026 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2-, RSK2+ Breast Cancer

PMD-026 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2-, RSK2+ Breast Cancer

BRIA-OTS Cell Therapy for Metastatic Breast Cancer

BRIA-OTS Cell Therapy for Metastatic Breast Cancer

Dual PARP and Microtubule Polymerization Inhibitor AMXI-5001 for Advanced Breast Cancer.

Dual PARP and Microtubule Polymerization Inhibitor AMXI-5001 for Advanced Breast Cancer.

A2B395 CAR T Cell Therapy for Advanced Breast Cancer That Expresses EGFR and Has Lost HLA Expression

A2B395 CAR T Cell Therapy for Advanced Breast Cancer That Expresses EGFR and Has Lost HLA Expression

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

STX-001 mRNA Injection with Pembrolizumab for Advanced Triple Negative Breast Cancer

STX-001 mRNA Injection with Pembrolizumab for Advanced Triple Negative Breast Cancer

TransCon IL-2 β/γ Immunotherapy with Trastuzumab or Trastuzumab Emtansine (T-DM1) for Metastatic 3rd Line or Later HER2+ Breast Cancer

TransCon IL-2 β/γ Immunotherapy with Trastuzumab or Trastuzumab Emtansine (T-DM1) for Metastatic 3rd Line or Later HER2+ Breast Cancer

Izalontamab Brengitecan Versus Chemotherapy for Advanced Triple Negative or ER Low Breast Cancer

Izalontamab Brengitecan Versus Chemotherapy for Advanced Triple Negative or ER Low Breast Cancer

Zongertinib Targeted Therapy with ADC for Advanced HER2+ Breast Cancer

Zongertinib Targeted Therapy with ADC for Advanced HER2+ Breast Cancer

LCB84 Antibody Drug Conjugate With and Without Immunotherapy for Advanced Breast Cancer

LCB84 Antibody Drug Conjugate With and Without Immunotherapy for Advanced Breast Cancer

Sacituzumab Govitecan ADC at a Different Dose and Schedule in Advanced Triple Negative Breast Cancer

Sacituzumab Govitecan ADC at a Different Dose and Schedule in Advanced Triple Negative Breast Cancer

Ifinatamab Deruxtecan ADC for Advanced HER2 Low or HER2 Negative Breast Cancer

Ifinatamab Deruxtecan ADC for Advanced HER2 Low or HER2 Negative Breast Cancer

GDC-4198 CDK2/4/6 Inhibitor Plus Giredestrant Oral SERD Versus Abemaciclib Plus Giredestrant for Advanced ER+, HER2- Breast Cancer

GDC-4198 CDK2/4/6 Inhibitor Plus Giredestrant Oral SERD Versus Abemaciclib Plus Giredestrant for Advanced ER+, HER2- Breast Cancer

Zelenectide Pevedotin Targeted Therapy for Advanced HR+, HER2- or Triple Negative Breast Cancer That Expresses NECTIN4

Zelenectide Pevedotin Targeted Therapy for Advanced HR+, HER2- or Triple Negative Breast Cancer That Expresses NECTIN4

BAY2927088 Targeted Therapy for Advanced Breast Cancer with HER2 Mutations

BAY2927088 Targeted Therapy for Advanced Breast Cancer with HER2 Mutations

Stereotactic Body Radiation Therapy and FES PET/CT Scans for Oligoprogressive Metastatic ER+ Breast Cancer

Stereotactic Body Radiation Therapy and FES PET/CT Scans for Oligoprogressive Metastatic ER+ Breast Cancer

Patritumab Deruxtecan for Advanced HR+, HER2- Breast Cancer

Patritumab Deruxtecan for Advanced HR+, HER2- Breast Cancer

APL-5125 Targeted Therapy for Advanced Triple Negative Breast Cancer

APL-5125 Targeted Therapy for Advanced Triple Negative Breast Cancer

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

GM1 to Reduce or Prevent Nerve Pain During Chemotherapy for Metastatic Breast Cancer

GM1 to Reduce or Prevent Nerve Pain During Chemotherapy for Metastatic Breast Cancer

MRT-2359 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

MRT-2359 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

ENV-501 Antibody Drug Conjugate for Advanced HR+, HER2-, HER3+ Breast Cancer