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1

Immunotherapy and Radiation for Advanced CEA Positive Breast Cancer

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of M5A-IL2, an experimental immunotherapy, with standard of care stereotactic body radiation therapy (SBRT).

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

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT), 3 sessions within 1 week</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">M5A-IL2 (M5A-ICK), by injection, 3 times within 3 days</li> <li class="seamTextUnorderedListItem">PET/CT scans</li> <li class="seamTextUnorderedListItem">MRI scans and/or <span class="highlight">bone</span> scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carcinoembryonic Antigen (CEA) is a protein that is present in some cancers, including breast cancer.</li> <li class="seamTextUnorderedListItem">M5A-IL2 (M5A-ICK) is an experimental immunotherapy called an immunocytokine.</li> <li class="seamTextUnorderedListItem">Immunocytokines are small proteins that regulate the activity of immune cells that are important for anti-cancer activity.</li> <li class="seamTextUnorderedListItem">The M5A-IL2 immunocytokine (M5A-ICK) combines the cancer targeting features of the M5A antibody with the immune system regulation properties of the cytokine IL-2.</li> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT) uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.</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/NCT06130826' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/managing-cancer/treatment-types/immunotherapy/cytokines.html' target='_blank'>American Cancer Society: Cytokines</a> </li></ul>
1

Immunotherapy and Radiation for Advanced CEA Positive Breast Cancer

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
At least 6 visits within 2 weeks

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ClinicalTrials.gov: NCT06130826

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Phase I

2

CycloSam <span class="highlight">Bone-Targeting</span> Radioactive Drug for Metastatic Breast Cancer with <span class="highlight">Bone</span> Metastases

A Dose Finding Study of CycloSam® (153-Sm-DOTMP) to Treat Solid Tumor(s) in the <span class="highlight">Bone</span> or Metastatic to the <span class="highlight">Bone</span> (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing's Sarcoma, and Other Solid Tumor(s) to the <span class="highlight">Bone</span> All Eligible)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of CycloSam®, an experimental radioactive drug.

Who is this for?: People with stage IV (metastatic) breast cancer that has spread to the <span class="highlight">bone</span> who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CycloSam®, by IV, 2 times within 1 week</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CycloSam®, also known as 153-Sm-DOTMP, is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">CycloSam® travels to the <span class="highlight">bone</span> and delivers radiation only to tumors in the <span class="highlight">bone.</li></span> <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/NCT06008483' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://qsambio.com/cyclosam/' target='_blank'>QSAM Biosciences: What is CycloSam®?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/metastatic/bone-metastasis' target='_blank'>Breastcancer.org: Metastasis to the Bone</a> </li></ul>
2

CycloSam <span class="highlight">Bone-Targeting</span> Radioactive Drug for Metastatic Breast Cancer with <span class="highlight">Bone</span> Metastases

A Dose Finding Study of CycloSam® (153-Sm-DOTMP) to Treat Solid Tumor(s) in the <span class="highlight">Bone</span> or Metastatic to the <span class="highlight">Bone</span> (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing's Sarcoma, and Other Solid Tumor(s) to the <span class="highlight">Bone</span> All Eligible)
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Nearest Location:
1634 miles
Clinical Trial Site
Houston, TX

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Visits:
2 visits within 1 week

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ClinicalTrials.gov: NCT06008483

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Phase I

3

Zunsemetinib Targeted Therapy with Chemotherapy for Metastatic HR+, HER2- Breast Cancer with <span class="highlight">Bone</span> Metastasis

A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With <span class="highlight">Bone</span> Metastasis

Purpose: To study the safety, best dose, and effects (good and bad) of zunsemetinib, an experimental targeted therapy, with chemotherapy compared to standard of care.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has spread to the <span class="highlight">bone</span> <span class="highlight">(bone</span> metastasis). You must have received 1 line of hormone therapy with a CDK4/6 inhibitor and no more than 1 line of chemotherapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bisphosphonate (zoledronic acid) or denosumab, every 1-3 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zunsemetinib, by mouth, daily</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">Zunsemetinib is an experimental targeted therapy called an MK2 inhibitor. Blocking MK2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Zunsemetinib targets a molecule that may play a role in inflammation and <span class="highlight">bone</span> loss.</li> <li class="seamTextUnorderedListItem">Bisphosphonate (zoledronic acid) and denosumab are standard of care drugs that help strengthen <span class="highlight">bones</span> but have little effect on pain relief and anti-cancer activity.</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/NCT06374459' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

Zunsemetinib Targeted Therapy with Chemotherapy for Metastatic HR+, HER2- Breast Cancer with <span class="highlight">Bone</span> Metastasis

A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With <span class="highlight">Bone</span> Metastasis
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Nearest Location:
1739 miles
Washington University School of Medicine
Saint Louis, MO

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Visits:
Weekly for 3 weeks, then 1 visit every 3 weeks

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ClinicalTrials.gov: NCT06374459

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Phase I-II

4

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) PD-1 inhibitor, gemcitabine (Gemzar®) and carboplatin (Paraplatin®) chemotherapy, and trilaciclib (Cosela®) CDK4/6 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. You must not have received more than 3 lines of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®), by IV, weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) also helps protect the <span class="highlight">bone</span> marrow from the side effects of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</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/NCT06027268' target='_blank'>ClinicalTrials.gov</a> </li></ul>
4

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)
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Nearest Location:
2299 miles
Levine Cancer Institute
Charlotte, NC

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT06027268

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Phase II

5

Abemaciclib CDK4/6 Inhibitor with Radiation for People with Metastatic HR+, HER2- Breast Cancer with <span class="highlight">Bone</span> Metastases

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer

Purpose: To test different doses of abemaciclib (Verzenio®) CDK4/6 inhibitor to find the best dose in people receiving radiation.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer with <span class="highlight">bone</span> metastases who are planning to receive radiation. View full eligibility criteria

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <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></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/NCT06678269' target='_blank'>ClinicalTrials.gov</a> </li></ul>
5

Abemaciclib CDK4/6 Inhibitor with Radiation for People with Metastatic HR+, HER2- Breast Cancer with <span class="highlight">Bone</span> Metastases

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer
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Nearest Location:
2539 miles
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, NJ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06678269

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Phase I

6

Studying <span class="highlight">Bone</span> Changes in Post-Menopausal Women with Stage I-IV Breast Cancer After Treatment with Aromatase Inhibitor and Denosumab

Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound <span class="highlight">Bone</span> Loss and Insufficiency Fractures After Denosumab Discontinuation

Purpose: To gather information about changes in the <span class="highlight">bones</span> after stopping treatment with an aromatase inhibitor and denosumab (Xgeva®).

Who is this for?: Postmenopausal women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have completed treatment with an aromatase Inhibitor before or within 6 months of completing at least 2 doses of denosumab (Xgeva®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physical exam, 5 visits within 2 years</li> <li class="seamTextUnorderedListItem">DEXA scan, 2 times within 2 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The physical exam will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work.</li> <li class="seamTextUnorderedListItem">Dual-energy X-ray absorptiometry (DEXA) scans use x-ray energy to measure <span class="highlight">bone</span> density (thickness and strength of <span class="highlight">bones).</li></ul></span>

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/NCT05590949' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/radiation-health/data-research/facts-stats/dexa-scan.html' target='_blank'>CDC: DEXA Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a610023.html' target='_blank'>MedlinePlus: Denosumab (Xgeva®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li></ul>
6

Studying <span class="highlight">Bone</span> Changes in Post-Menopausal Women with Stage I-IV Breast Cancer After Treatment with Aromatase Inhibitor and Denosumab

Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound <span class="highlight">Bone</span> Loss and Insufficiency Fractures After Denosumab Discontinuation
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
5 visits

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ClinicalTrials.gov: NCT05590949

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Phase NA

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