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Find Breast Cancer Clinical Trials That Are Right For You
The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.
Use the search box and filters to find a trial that’s right for you.
Currently viewing trials
(Last updated: June 18, 2025)
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Treatment
Brain Mets
BRCA1/2 (inherited)
Chemotherapy
Hormone Therapy
Leptomeningeal Disease
Radiation Oncology
Surgery
Surgery: Reconstruction
Targeted Therapy: All
Targeted Therapy: ADC
Targeted Therapy: Anti-HER2 Therapy
Targeted Therapy: CDK Inhibitors
Targeted Therapy: PARP Inhibitors
Targeted Therapy: Tumor Mutations
Targeted Therapy: Other Targeted Therapy
Vaccines and Immunotherapy
Other Treatment
Non-Treatment
Activities
Complementary and Integrative Medicine
Decision Support
Diagnosing Breast Cancer
Genetics/Family History
Having Children
Healthy/High Risk
Imaging
Lymphedema
Managing Side Effects
No Travel Required
Predicting Response to Treatment
Preventing Breast Cancer
Preventing Recurrence
Support/Education
Surveys/Interviews/Registries
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AKT
ALK
AR
BARD1
BRCA1/2 (tumor)
BRIP1
CD205
CD70
CHEK2 or CHEK1
dMMR/MSI-H
ESR1
FGFR
HER2/ERBB2
HLA
MET or C-Met
NTRK
PALB2
PIK3CA or PI3K
PTEN
RAD51
RAF (including BRAF)
RAS (KRAS or NRAS)
RB
ROS1
TP53
1
NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA
VISITS: 1 visit every 1-2 weeks for 5 months
PHASE: III
NCT ID: NCT06058377
Chemotherapy with Durvalumab Immunotherapy Before Surgery for Women with Stage II-III HR+, HER2- Breast Cancer
Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of standard of care neoadjuvant (before surgery) chemotherapy with and without durvalumab (Imfinzi®) PD-L1 inhibitor.
Who is this for?
Women with newly diagnosed stage II or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment. You must have a MammaPrint score of -1.0 to -0.57.
Full eligibility criteria
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<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">Mammogram</li> <li class="seamTextUnorderedListItem">MammaPrint testing (if not yet received)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2 weeks 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram</li> <li class="seamTextUnorderedListItem">MammaPrint testing (if not yet received)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2 weeks 2 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly for 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs.</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">A mammogram is a breast cancer screening procedure involving taking an x-ray picture of the breast.</li> <li class="seamTextUnorderedListItem">MammaPrint® is a genetic test that use tumor samples to help guide treatment decisions and determine risk of recurrence (cancer coming back).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06058377' 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://medlineplus.gov/druginfo/meds/a617030.html#:~:text=Durvalumab%20injection%20is%20in%20a,the%20growth%20of%20cancer%20cells.' target='_blank'>Medline Plus: Durvalumab (Imfinzi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint Test</a> </li></ul>
2
NEAREST SITE: 3 miles
UCSF Medical Center-Mission Bay
San Francisco,CA
VISITS: Please contact research site
PHASE: II
NCT ID: NCT05564377
ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer
Molecular Analysis for Combination Therapy Choice (ComboMATCH) Scientific Title
Purpose
To use genetic testing to match people to treatments and help doctors plan better treatments.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 1 line of therapy for advanced disease or who have no standard treatment options available.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy based on genetic testing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic tests look at the unique genetic material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>
3
NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT05694715
Niraparib Targeted Therapy and Irinotecan Chemotherapy for Advanced Breast Cancer with BRCA1, BRCA2, ATM, and PALB2 Mutations
Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of niraparib PARP inhibitor with irinotecan chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer with a BRCA1, BRCA2, ATM, and/or PALB2 mutation.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, 1 week on, 2 weeks off</li> <li class="seamTextUnorderedListItem">Irinotecan (Camptosar®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Irinotecan (Camptosar®) is a type of chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) and irinotecan (Camptosar®) are approved to treat certain types of cancer. Their use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, ATM, PALB2</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05694715' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617007.html' target='_blank'>Medline Plus: Niraparib (Zejula®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a608043.html' target='_blank'>Medline Plus: Irinotecan (Camptosar®)</a> </li></ul>
4
NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT05879926
Hormone Therapy and Ovarian Suppression With or Without Chemotherapy for Premenopausal Women with Stage I-III HR+, HER2- Breast Cancer
A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of adding chemotherapy to treatment with aromatase inhibitor and ovarian function suppression.
Who is this for?
Premenopausal women 18-60 years old with stage I, stage II, or some stage III hormone receptor positive or low (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer who have received surgery and have an Oncotype DX score of less than 26.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, 5 years</li> <li class="seamTextUnorderedListItem">Ovarian function suppression, every 1-3 months, 5 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, 5 years</li> <li class="seamTextUnorderedListItem">Ovarian function suppression, every 1-3 months, 5 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy that block some production of estrogen that helps cancer grow. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Ovarian suppression can stop the ovaries from making estrogen, putting you into temporary menopause. This prevents the tumor from receiving estrogen it needs to grow.</li> <li class="seamTextUnorderedListItem">The Oncotype DX test can help determine the chance of the cancer coming back and whether a person will benefit from chemotherapy.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05879926' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/hormone-therapy/ovarian-suppression/' target='_blank'>Susan G. Komen: Ovarian Suppression</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/oncotype-dx' target='_blank'>Breastcancer.org: Oncotype DX</a> </li></ul>
5
NEAREST SITE: 3 miles
UCSF Medical Center
San Francisco,CA
VISITS: 1-2 visits every 3 weeks for 6 months
PHASE: III
NCT ID: NCT05633654
Sacituzumab Govitecan with Pembrolizumab for Stage I-III Triple Negative Breast Cancer with Residual Disease
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab govitecan (Trodelvy®) antibody drug conjugate with pembrolizumab (Keytruda®) immunotherapy, a PD-1 inhibitor.
Who is this for?
People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer with residual disease after neoadjuvant (before surgery) treatment and surgery. You must not have a BRCA mutation.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off, 6 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months (optional)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 6 months</li></ul>
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<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">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">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells that are present after treatment.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05633654' target='_blank'>ClinicalTrials.gov</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/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>
6
NEAREST SITE: 3 miles
University of California San Francisco (UCSF)
San Francisco,CA
VISITS: 1 visit every week for 3-6 months
PHASE: II
NCT ID: NCT01042379
I-SPY 2: Personalized Treatment Before Surgery for Stage II-III Breast Cancer
I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of standard of care therapy compared to standard of care therapy with an experimental drug chosen based on your tumor's biomarkers.
Who is this for?
People with stage II or stage III breast cancer who have not yet received treatment and whose cancer is high-risk for recurrence.
Full eligibility criteria
Contact research site
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- What's being studied?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and receive the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">At least 1 experimental therapy chosen based on your tumor's biomarkers</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy is treatment specific to an individual's tumor type, which are called biomarkers.</li> <li class="seamTextUnorderedListItem">This clinical trial has an adaptive design. This means that experimental drugs will be added during the trial, and experimental drugs that are not more effective than standard of care therapy will be removed.</li> <li class="seamTextUnorderedListItem">At least 80% of people who enroll will receive an experimental drug.</li> <li class="seamTextUnorderedListItem">All drugs will be given before surgery (neoadjuvant therapy). This allows researchers to see how your tumor is responding to the drugs.</li> <li class="seamTextUnorderedListItem">For this trial, cancer is considered high-risk for recurrence if it tests MammaPrint Low (only if your tumor is ER- or ER+, HER2+) or MammaPrint High.</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test that identifies genes in your tumor and gives two types of recurrence risk scores: low risk or high risk.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ispypatient.org/' target='_blank'>Quantum Leap Healthcare Collaborative: I-SPY Patient Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/32701140/' target='_blank'>Journal Article: Three-Year Follow-Up Analysis for the I-SPY 2 Adaptively Randomized Clinical Trial</a> </li></ul>
7
NEAREST SITE: 3 miles
University of California San Francisco (Data collection only)
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT06099769
Enzalutamide Alone or With Mifepristone for Advanced Triple Negative or ER Low, Androgen Receptor Positive Breast Cancer
A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of enzalutamide (Xtandi®), an experimental hormone therapy, alone or with mifepristone, an experimental hormone therapy, compared to standard of care chemotherapy.
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 ER low, androgen receptor positive (AR+) breast cancer who have received 0-1 lines of chemotherapy for advanced disease.
Full eligibility criteria
Contact research site
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- What's being studied?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Mifepristone, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®) is an anti-androgen hormone therapy approved for people with prostate cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Mifepristone is an anti-progesterone hormone therapy. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), paclitaxel (Taxol®), capecitabine (Xeloda®), and eribulin (Halaven®) are standard of care chemotherapy medications used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">If you are in group 3, you may be able to switch to group 2 if your cancer progresses.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06099769' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>Medline Plus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
8
NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA
VISITS: 1 visit every 3 weeks, for 1 year
PHASE: II
NCT ID: NCT04893109
Trastuzumab by Injection with Chemotherapy or an Antibody-Drug Conjugate for Stage I HER2 Positive Breast Cancer
A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0) Scientific Title
Purpose
To study and compare the safety, side effects, and anti-cancer activity of giving Herceptin Hylecta (trastuzumab by injection) with chemotherapy to giving it with an antibody-drug conjugate.
Who is this for?
People with stage I HER2-positive (HER2+) breast cancer who have already had surgery and completed radiation therapy.
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 4.5 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)/Herceptin Hylecta, by injection, every 3 weeks, for 7.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)/Herceptin Hylecta, by injection, every 3 weeks, for 11.5 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody -— the HER2-targeted therapy trastuzumab (Herceptin®) -— to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2 positive 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">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04893109' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-formulation-herceptin-subcutaneous-use' target='_blank'>FDA Drug Approvals and Database: FDA Approves New Formulation of Herceptin for subcutaneous Use</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine/T-DM1 (Kadcyla®)</a> </li></ul>
9
NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT05929768
Shorter Chemotherapy and Immunotherapy Treatment Before Surgery for Stage I-III Triple Negative Breast Cancer
Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of shorter chemotherapy and immunotherapy treatment without doxorubicin (Adriamycin®) chemotherapy before surgery (neoadjuvant).
Who is this for?
People with stage I, stage II, or some stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have not yet received treatment.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> <li class="seamTextUnorderedListItem">Carboplatin (Carboplatin®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, before and/or after surgery</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, before and/or after surgery</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), carboplatin (Paraplatin®), paclitaxel (Taxol®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs commonly used to treat 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">Shorter chemotherapy treatment without doxorubicin (Adriamycin®) chemotherapy may work the same as usual chemotherapy treatment for stage I-III triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05929768' 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/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
10
NEAREST SITE: 5 miles
University of California, San Francisco
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05315700
ORIC-114 Targeted Therapy for Advanced HER2+ Breast Cancer
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 Scientific Title
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.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and/or pemetrexed (Alimta®)</li></ul>
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<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>
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<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>
11
NEAREST SITE: 27 miles
Stanford University Medical Center
Stanford,CA
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05514717
XMT-2056 ADC for Advanced HER2+ or HER2 Mutated Breast Cancer
A Phase 1, First in Human, Dose Escalation and Expansion, Multicenter Study of XMT-2056 in Participants With Advanced/Recurrent Solid Tumors That Express HER2 Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of XMT-2056, an experimental antibody drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer or breast cancer with a HER2 mutation who have received standard treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056 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">XMT-2056's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called Immunosynthen.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05514717' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/pipeline/overview/' target='_blank'>Mersana Therapeutics Drug Information Page: XMT-2056</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/our-technology-platforms/about-adcs/' target='_blank'>Mersana Therapeutics: About ADCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/our-technology-platforms/immunosynthen/' target='_blank'>Mersana Therapeutics: Immunosynthen</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>
12
NEAREST SITE: 27 miles
Stanford Cancer Institute
Palo Alto,CA
VISITS: 1 visit per month
PHASE: II
NCT ID: NCT05305365
QBS72S Chemotherapy for Metastatic Triple Negative Breast Cancer with Brain or Leptomeningeal Metastasis
A Phase IIa Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of QBS72S, an experimental chemotherapy.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) or leptomeningeal metastasis visible on an MRI who have received chemotherapy. If you have brain metastasis, you must have at least 1 lesion that has not received treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">QBS72S, by IV, monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">QBS72S is an experimental chemotherapy that may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Leptomeningeal metastasis (LM) is when cancer has spread to the leptomeninges, also called leptomeningeal carcinomatosis, leptomeningeal disease (LMD), leptomeningeal cancer, neoplastic meningitis, meningeal metastasis, and meningeal carcinomatosis, among other names.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05305365' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quadrigabiosciences.com/science/' target='_blank'>Quadriga Biosciences: QBS72S Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
13
NEAREST SITE: 28 miles
Stanford University
Stanford,CA
VISITS: 2 visits within 6 months
PHASE: II
NCT ID: NCT04768426
ctDNA Monitoring During Chemotherapy for Stage I-III Triple Negative Breast Cancer
Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy Scientific Title
Purpose
To use circulating tumor DNA (ctDNA) to identify who will or will not experience benefit from adjuvant (after surgery) capecitabine (Xeloda®) chemotherapy.
Who is this for?
People with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have residual disease after neoadjuvant (before surgery) chemotherapy and surgery. You must be planning to receive capecitabine (Xeloda®) after surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> <li class="seamTextUnorderedListItem">Blood test, 2 times within 6 months</li></ul>
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<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">ctDNA tests are also called liquid biopsies.</li> <li class="seamTextUnorderedListItem">In this study, changes in ctDNA in the blood will be monitored over time during capecitabine (Xeloda®) treatment and related to genetic mutations in tumors. </li> <li class="seamTextUnorderedListItem">Results from this study may provide information for future clinical trials in which patients receive a different treatment than capecitabine (Xeloda®) to reduce their risk of breast cancer coming back (recurrence).</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after treatment.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04768426' target='_blank'>ClinicalTrials.gov</a> </li></ul>
14
NEAREST SITE: 28 miles
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT06449222
BNT327 with Chemotherapy for Advanced Triple Negative Breast Cancer
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 Scientific Title
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.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT327, by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV</li></ul>
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<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>
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<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>
15
NEAREST SITE: 53 miles
Providence Medical Group Santa Rosa - Cancer Center
Santa Rosa,CA
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT05891171
AB598 Immunotherapy for Advanced Triple Negative Breast Cancer
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of AB598, an experimental CD39 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no standard treatment options available.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB598, by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB598 is an experimental immunotherapy called a CD39 inhibitor. Blocking CD39 may help the immune system to find and attack cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05891171' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://arcusbio.com/our-science/discovery-candidates/' target='_blank'>Arcus Biosciences: AB598 Drug Information Page</a> </li></ul>
16
NEAREST SITE: 53 miles
Research Site
Santa Rosa,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT06103864
Dato-DXd ADC With or Without Durvalumab Immunotherapy for Advanced Triple Negative, PD-L1 Positive Breast Cancer
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast (TROPION-Breast05) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of datopotamab deruxtecan (Dato-DXd), an experimental antibody drug conjugate (ADC), with or without durvalumab immunotherapy compared to standard of care chemotherapy with pembrolizumab immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), PD-L1 positive breast cancer who have not yet received treatment for advanced disease.
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-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">Datopotamab deruxtecan's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) and pembrolizumab (Keytruda®) are a type of immunotherapy called PD-1 inhibitors, which are 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">In this trial, standard of care chemotherapy drugs include carboplatin (Paraplatin®), paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), and/or gemcitabine (Gemzar®).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06103864' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazenecaclinicaltrials.com/study/D7630C00001/' target='_blank'>AstraZeneca: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/october-10-2022-supplement-breast-cancer-almanac/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Datopotamab Deruxtecan (Dato-DXd)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/news/conference-coverage/asco-2021/asco-2021-breast-cancer-in-depth/breast-cancer-durvalumab-neoadjuvant-chemo-treatment-risk/#:~:text=June%2024%2C%202021-,Durvalumab%20Improves%20Survival%20When%20Added%20to,in%2' target='_blank'>Cancer Therapy Advisor: Durvalumab (Imfinzi®)</a> </li></ul>
17
NEAREST SITE: 74 miles
University of California Davis Comprehensive Cancer Center
Sacramento,CA
VISITS: Number of visits varies, ongoing
PHASE: II
NCT ID: NCT03606967
Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is PD-L1 Negative
Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety and anti-cancer activity of giving chemotherapy, the immunotherapy tremelimumab, and the PD-L1 inhibitor Durvalumab (Imfinzi®) together with or without a personalized synthetic long peptide (SLP) vaccine and Hiltonol® (poly-ICLC) .
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that is PD-L1 negative and who have not yet received any treatment for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Vaccine</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized SLP Vaccine and Hiltonol® (poly-ICLC), 7 times over 2.5 months</li> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: No Vaccine</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The type of vaccine used in this trial is called a personalized synthetic long peptide (SLP) vaccine. It may help your immune system see and fight cancer cells. </li> <li class="seamTextUnorderedListItem">Hiltonol® (poly-ICLC) is an immune cell activating factor.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy routinely used to treat advanced and metastatic triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Tremelimumab is a type of immunotherapy called a CTLA-4 inhibitor.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It works by stimulating the body's immune system to go after cancer cells. It has been approved to treat certain types of cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat advanced breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03606967' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/breast-cancer-treatment-vaccines/' target='_blank'>Metastatic Trial Talk: Breast Cancer Treatment Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search/Personalized%20Synthetic%20Long%20Pe/?searchMode=Begins' target='_blank'>NCI Drug Dictionary: Personalized Synthetic Long Peptide Breast Cancer Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com' target='_blank'>Oncovir Drug Information Page: Hiltonol® (poly-ICLC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Tremelimumab' target='_blank'>Wikipedia: Tremelimumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/durvalumab' target='_blank'>NCI Drug Dictionary: Durvalumab (Imfinzi®)</a> </li></ul>
18
NEAREST SITE: 75 miles
Research Site 1143-0
Sacramento,CA
VISITS: 1 visit every 1-3 weeks
PHASE: III
NCT ID: NCT06018337
DB-1303/BNT323 Antibody Drug Conjugate for Advanced HR+, HER2 Low Breast Cancer
A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of DB-1303/BNT323, an experimental antibody drug conjugate (ADC).
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 1-2 lines of therapy for advanced disease. You must not have received chemotherapy for advanced disease or any anti-HER2 targeted therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DB-1303/BNT323, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">One of the following:</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DB-1303/BNT323 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">DB-1303/BNT323's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®), paclitaxel (Taxol®), or nab-paclitaxel (Abraxane®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06018337' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dualitybiologics.com/pipeline.html' target='_blank'>DualityBio: DB-1303 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dualitybiologics.com/approach.html?md=1' target='_blank'>DualityBio: ADC 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>
19
NEAREST SITE: 186 miles
Renown Regional Medical Center
Reno,NV
VISITS: 1 visit every 3 weeks
PHASE: III
NCT ID: NCT05894239
Inavolisib and Phesgo for Advanced HER2 Positive Breast Cancer with a PIK3CA Mutation
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer... Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of inavolisib, an experimental PI3K inhibitor, with Phesgo anti-HER2 targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer with a PIK3CA mutation who have not received treatment for advanced disease (except for hormone therapy if HR+).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy (optional, if relevant)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy (optional, if relevant)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will first receive induction therapy (initial therapy used when treating a disease) with Phesgo and chemotherapy.</li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Phesgo is a combination of two anti-HER2 targeted therapies: Perjeta® (pertuzumab) and Herceptin® (trastuzumab). It also includes a protein called hyaluronidase which helps your body absorb the targeted therapies.</li> <li class="seamTextUnorderedListItem">Pertuzumab and trastuzumab are typically given by IV. With Phesgo, you can receive these therapies by injection, which shortens the length of time it takes to receive treatment.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05894239' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/medical-professionals/pipeline/inavolisib-gdc-0077' target='_blank'>Genentech: Inavolisib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/phesgo' target='_blank'>Breastcancer.org: Phesgo</a> </li></ul>
20
NEAREST SITE: 186 miles
Renown Regional Medical Center ( Site 0005)
Reno,NV
VISITS: At least 1 visit every 1-4 weeks
PHASE: III
NCT ID: NCT06841354
Sacituzumab Tirumotecan ADC With and Without Immunotherapy for Advanced Triple Negative Breast Cancer
A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing..(MK-2870-011) (TroFuse-011) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab tirumotecan, an experimental antibody drug conjugate (ADC), alone or with pembrolizumab (Keytruda®) immunotherapy compared to standard of care chemotherapy.
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 cancer must express PD-L1 at a combined positive score (CPS) of less than 10.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (Sac-TMT, MK-2870), by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (Sac-TMT, MK-2870), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy, by IV, every 1-4 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan 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">Sacituzumab tirumotecan's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug.</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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06841354' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/july-10-2024/novel-antibody-drug-conjugate-extends-survival-vs-chemotherapy-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Sacituzumab Tirumotecan ADC Extends Survival vs. Chemotherapy in Triple Negative Breast Cancer</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>
21
NEAREST SITE: 250 miles
Research Site
Bakersfield,CA
VISITS: 1 visit every 1-3 weeks for 1 year
PHASE: III
NCT ID: NCT06112379
Dato-DXd ADC and Immunotherapy Before Surgery for Stage II-III Triple Negative or HR Low, HER2- Breast Cancer
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Tr... Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) datopotamab deruxtecan (Dato-DXd), an experimental antibody drug conjugate, and durvalumab (Imfinzi®) PD-1 inhibitor with or without chemotherapy compared to standard of care.
Who is this for?
People with newly diagnosed stage II or stage III triple negative (ER-, PR-, HER2-) or hormone receptor low (ER low and/or PR low), HER2 negative (HER2-) breast cancer who have not yet received treatment.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, every 3 weeks, for 6 months before surgery</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, for 6 months before surgery</li> </ul> <p class="seamTextPara"> followed by (after surgery): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Chemotherapy (if residual disease is found)</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth (if applicable)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, before surgery</li> <li class="seamTextUnorderedListItem">Chemotherapy, before surgery</li> </ul> <p class="seamTextPara"> followed by (after surgery): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Chemotherapy (if residual disease is found)</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth (if applicable)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd) is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) combines an antibody that targets cancer cells with a therapy that kills cancer cells.</li> <li class="seamTextUnorderedListItem">Because it only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Dato-DXd's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) and pembrolizumab (Keytruda®) are types of immunotherapy called PD-L1 inhibitors, which are 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">Olaparib (Lynparza®) is a targeted therapy called a PARP inhibitor, which work by blocking the action of an enzyme that helps repair DNA. It will be given to people with residual disease and BRCA positive (BRCA+) tumors.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06112379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html#oncology' target='_blank'>AstraZeneca: Datopotamab Deruxtecan (Dato-DXd) Drug Information Page</a> </li></ul>
22
NEAREST SITE: 250 miles
Comprehensive Blood and Cancer Center
Bakersfield,CA
VISITS: May require hospitalization
PHASE: III
NCT ID: NCT06072612
Bria-IMT Cell Therapy for Advanced Breast Cancer
Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer. Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of the Bria-IMT regimen, an experimental cell therapy, alone and with retifanlimab (Zynyz®) PD-1 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Bria-IMT Regimen with Immunotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 day every 3 weeks</li> <li class="seamTextUnorderedListItem">SV-BR-1-GM, by injection, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Interferon, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Retifanlimab (Zynyz®), by infusion, every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Bria-IMT Regimen Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 day every 3 weeks</li> <li class="seamTextUnorderedListItem">SV-BR-1-GM, by injection, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Interferon, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Bria-IMT regimen is an experimental cell therapy with SV-BR-1-GM 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">Interferon is an immunotherapy used to regulate your immune response to the cell therapy.</li> <li class="seamTextUnorderedListItem">Retifanlimab (Zynyz®) 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 called the BRIA-ABC trial.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06072612' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://briacell.com/briaimt/' target='_blank'>BriaCell Therapeutics: Bria-IMT Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/retifanlimab-dlwr' target='_blank'>National Cancer Institute: Retifanlimab (Zynyz®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
23
NEAREST SITE: 304 miles
FOMAT Medical Research
Oxnard,CA
VISITS: 1 visit every 3 months
PHASE: II
NCT ID: NCT06568692
Eniluracil Targeted Therapy with Chemotherapy for Advanced HER2- Breast Cancer
A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer Scientific Title
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.
Full eligibility criteria
Contact research site
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- What's being studied?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eniluracil (PCS6422), 1 time</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily</li></ul>
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<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>
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<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>
24
NEAREST SITE: 304 miles
FOMAT Medical Research (Network)
Oxnard,CA
VISITS: At least 5 visits every 3 weeks
PHASE: II
NCT ID: NCT06764940
Utidelone Chemotherapy for Metastatic HER2- or HER2 Low Breast Cancer with Brain Metastases
A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases Scientific Title
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).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
25
NEAREST SITE: 336 miles
UCLA Medical Center
Los Angeles,CA
VISITS: 1 visit every 3 weeks for 9 months, then every 1.5 months
PHASE: I-II
NCT ID: NCT06247995
Radioactive Drug with Chemotherapy for Metastatic ER+, HER2- or HER2 Low, GRPR+ Breast Cancer
A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inh...(NeoB-Cap1) Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of 177Lu-Lu-NeoB, an experimental radioactive drug, with capecitabine (Cytoxan®) chemotherapy.
Who is this for?
People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer that is GRPR positive (GRPR+) who have received no more than 3 lines of hormone therapy (including a CDK4/6 inhibitor) for metastatic disease. You must not have received more than 1 line of chemotherapy or antibody drug conjugate (ADC) for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB, by IV, every 3-6 weeks</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">PET/CT or PET/MRI scan with 68Ga-Ga-NeoB, by IV, 1-2 times</li></ul>
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<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-Lu-NeoB is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB targets tumors that are positive for GRPR (gastrin releasing peptide receptor).</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®) 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> <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 experimental tracer in this study is 68Ga-Ga-NeoB.</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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06247995' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/NCT06247995' target='_blank'>Novartis: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.moffitt.org/diagnostic-services/radiology-diagnostic-imaging-and-interventional-radiology/services-and-locations/radiopharmaceuticals/#:~:text=Radiopharmaceuticals%20are%20a%20unique%20class,linker%20that%20joins%20the%20two.' target='_blank'>Moffitt Cancer Center: Radiopharmaceuticals</a> </li></ul>
26
NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA
VISITS: 3 visits every month, ongoing
PHASE: I
NCT ID: NCT03129139
Minnelide™ Capsules and Chemotherapy for Metastatic Breast Cancer
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors Scientific Title
Purpose
To evaluate the safety and effects (good and bad) of using Minnelide™ along with the chemotherapy protein-bound paclitaxel (Abraxane®).
Who is this for?
People with metastatic (stage IV) breast cancer and have no standard cancer treatment options available.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Minnelide™, by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Abraxane® (protein-bound paclitaxel), by IV, once a week (3 weeks on, 1 week off), ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Minnelide™ is an experimental heat shock protein (HSP) inhibitor. </li> <li class="seamTextUnorderedListItem">Abraxane is used to treat metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of cancers.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03129139' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/protein-bound-paclitaxel' target='_blank'>NCI Dictionary of Cancer Terms: Protein-bound Paclitaxel</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/triptolide-analogue' target='_blank'>NCI Drug Dictionary: Triptolide Analogue (Minnelide™)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4515388/' target='_blank'>Journal Article: Minnelide™ for Pancreatic and Liver Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abraxane.com/mbc/' target='_blank'>Drug Company Information Page: Abraxane</a> </li></ul>
27
NEAREST SITE: 348 miles
USC/Norris Comprehensive Cancer Center
Los Angeles,CA
VISITS: 1 visit every 3 weeks
PHASE: I-II
NCT ID: NCT04333706
Sarilumab Immunotherapy with Chemotherapy After Surgery for Stage I-III Triple Negative Breast Cancer
A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER) Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of sarilumab (Kevzara®) immunotherapy with capecitabine (Xeloda®) chemotherapy.
Who is this for?
People with stage I, stage II or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer with residual disease (cancer that remains after surgery).
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sarilumab (Kevzara®), by injection, every 3 weeks, up to 3 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, up to 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, up to 6 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Sarilumab (Kevzara®) is approved to treat people with certain types of arthritis. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Sarilumab (Kevzara®) targets a molecule made by the immune system and may have anti-cancer effects.</li> <li class="seamTextUnorderedListItem">Residual disease is cancer that remains after surgery.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04333706' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617032.html' target='_blank'>Medline Plus: Sarilumab Drug Information Page</a> </li></ul>
28
NEAREST SITE: 348 miles
USC-Norris Comprehensive Cancer Center - Investigational Drug Service IDS
Los Angeles,CA
VISITS: Approximately 1 visit every 1-2 weeks
PHASE: III
NCT ID: NCT06435429
Zanidatamab Targeted Therapy with Chemotherapy for Advanced HER2 Positive Breast Cancer
A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, o... Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab, an experimental anti-HER2 targeted therapy, with chemotherapy compared to trastuzumab (Herceptin®) anti-HER2 targeted therapy with chemotherapy.
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).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab, by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-2 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab 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">Zanidatamab is a bispecific antibody that binds to 2 targets on HER2.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, the chemotherapy drugs are eribulin (Halaven®), gemcitabine (Gemzar®), vinorelbine (Navelbine®), or capecitabine (Xeloda®).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06435429' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/zanidatamab-combo-appears-exciting-in-her2-hr-metastatic-breast-cancer' target='_blank'>CancerNetwork: Zanidatamab Combo Appears ‘Exciting’ in HER2+/HR+ Metastatic Breast Cancer</a> </li></ul>
29
NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA
VISITS: 5 visits within 6 months
PHASE: II
NCT ID: NCT06042569
Lower Chemotherapy Doses for Older Women with Stage I-III HER2 Negative Breast Cancer
Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY) Scientific Title
Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of lower and standard doses of docetaxel (Taxotere®) chemotherapy with cyclophosphamide (Cytoxan®) chemotherapy.
Who is this for?
Women at least 65 years old with stage I, stage II, or stage III HER2 negative (HER2-) breast cancer who are planning to receive chemotherapy with docetaxel (Taxotere®) and cyclophosphamide (Cytoxan®).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lower dose docetaxel (Taxotere®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months </li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard dose docetaxel (Taxotere®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy drugs, such as cyclophosphamide (Cytoxan®) and docetaxel (Taxotere®), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. </li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and docetaxel (Taxotere®) are not well tolerated at the standard dose and can affect the way older people feel physically and emotionally.</li> <li class="seamTextUnorderedListItem">Giving a lower dose may be an effective treatment option and improve quality of life in older women.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06042569' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxotere' target='_blank'>Breastcancer.org: Docetaxel (Taxotere®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li></ul>
30
NEAREST SITE: 362 miles
Innovative Clinical Research Institute
Whittier,CA
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT05593094
ZN-A-1041 Targeted Therapy for Advanced HER2 Positive or HER2 Low Breast Cancer
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ZN-A-1041, an experimental anti-HER2 targeted therapy, with other anti-HER2 targeted therapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low (IHC 2+) breast cancer who have no standard treatment options available. You must have received treatment with trastuzumab (Herceptin®) and chemotherapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-Dxd), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Pertuzumab/trastuzumab (PHESGO®), by injection, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041 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 emtansine (T-DM1, Kadcyla®) and trastuzumab deruxtecan (T-Dxd, Enhertu®) are antibody drug conjugates (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">Trastuzumab emtansine and trastuzumab deruxtecan target HER2 and deliver anti-cancer drugs.</li> <li class="seamTextUnorderedListItem">Pertuzumab/trastuzumab (PHESGO®) is a combination of two anti-HER2 targeted therapies, pertuzumab (Perjeta®) and trastuzumab (Herceptin®). You may also receive the two drugs separately.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05593094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.businesswire.com/news/home/20200907005109/en/Zion-Pharma-Announces-Initiation-of-Phase-1-Study' target='_blank'>Zion Pharma Press Release: ZN-A-1041</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab emtansine (T-DM1, Kadcyla®)</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><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/phesgo' target='_blank'>Breastcancer.org: Pertuzumab/trastuzumab (PHESGO®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li></ul>
31
NEAREST SITE: 366 miles
Cancer and Blood Specialty Clinic
Los Alamitos,CA
VISITS: 1 visit every 1-2 weeks
PHASE: I-II
NCT ID: NCT05933265
LP-184 Chemotherapy for Advanced Triple Negative Breast Cancer or Breast Cancer with DNA Damage Mutations
A Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients with Advanced or Metastatic Solid Tumors Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of LP-184, an experimental chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or breast cancer with a DNA damage mutation who have no standard treatment options available.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LP-184, by IV, weekly, 2 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LP-184 is an experimental chemotherapy drug causing tumor cell death through DNA damage.</li> <li class="seamTextUnorderedListItem">DNA damage mutations may include BRCA1, BRCA2, PALB2, ATM, CHEK2, and others.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05933265' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lanternpharma.com/clinical-trials' target='_blank'>Lantern Pharma: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lanternpharma.com/compassionate-use#ExpandedAccessTNBC' target='_blank'>Lantern Pharma: LP-184 Compassionate Use for Triple Negative Breast Cancer</a> </li></ul>
32
NEAREST SITE: 366 miles
Cancer and Blood Specialty Clinic ( Site 0001)
Los Alamitos,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT06312176
Sacituzumab Tirumotecan ADC for Advanced HR+, HER2- Breast Cancer
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab tirumotecan, an experimental antibody drug conjugate (ADC), alone or with pembrolizumab (Keytruda®) PD-1 inhibitor, compared to standard of care chemotherapy.
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 hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received chemotherapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (MK-2870), by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (MK-2870), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (MK-2870) 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 sacituzumab tirumotecan (MK-2870) targets TROP2 proteins. It delivers the chemotherapy belotecan.</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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06312176' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: Sacituzumab Tirumotecan (MK-2870) Drug Information Page</a> </li></ul>
33
NEAREST SITE: 374 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange,CA
VISITS: 1 visit every week for 4 months
PHASE: II
NCT ID: NCT05751668
GM1 to Reduce or Prevent Nerve Pain During Chemotherapy for Metastatic Breast Cancer
An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy Scientific Title
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.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <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>
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<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>
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<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>
34
NEAREST SITE: 386 miles
Loma Linda University Cancer Center
Loma Linda,CA
VISITS: 1-2 visits within 1-2 days
PHASE: III
NCT ID: NCT03598426
3 Regimens to Prevent Allergic Reactions to Chemotherapy for Women with Stage I-IV Breast Cancer
Conventional Prophylactic Regimen of Oral Dexamethasone Versus Short-course Intravenous Dexamethasone in Preventing Paclitaxel-related Hypersensitivity Reactions in Breast and Gynecologic Oncology Patients: A Prospective, Randomized, Open-label Study Scientific Title
Purpose
To compare the ability of 3 regimens of dexamethasone, diphenhydramine (Benadryl®), and famotidine to prevent allergic reactions to paclitaxel (Taxol®) chemotherapy.
Who is this for?
Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive paclitaxel (Taxol®).
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth</li> </ul> <p class="seamTextPara"> followed 1 day later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Diphenhydramine (Benadryl®), by IV</li> <li class="seamTextUnorderedListItem">Famotidine, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, by IV</li> <li class="seamTextUnorderedListItem">Diphenhydramine (Benadryl®), by IV</li> <li class="seamTextUnorderedListItem">Famotidine, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth</li> </ul> <p class="seamTextPara"> followed 1 day later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, by IV</li> <li class="seamTextUnorderedListItem">Diphenhydramine (Benadryl®), by IV</li> <li class="seamTextUnorderedListItem">Famotidine, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Dexamethasone, diphenhydramine (Benadryl®), and famotidine are drugs that help prevent allergic reactions to chemotherapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03598426' 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><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a687011.html' target='_blank'>MedlinePlus: Famotidine</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682792.html' target='_blank'>MedlinePlus: Dexamethasone</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682539.html' target='_blank'>MedlinePlus: Diphenhydramine (Benadryl®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/side_effects/allergic' target='_blank'>Breastcancer.org: Allergic Reactions</a> </li></ul>
35
NEAREST SITE: 414 miles
Optum Care Cancer Center ( Site 0004)
Las Vegas,NV
VISITS: 1 visit every week for 3 months, then 1 visit every 3-6 weeks for 1 year
PHASE: II
NCT ID: NCT06829199
Boserolimab Immunotherapy with Standard of Care for Stage II-III Triple Negative Breast Cancer
A Phase 2, Umbrella Study to Evaluate the Safety, Tolerability, and Clinical Activity of Investigational Agents for Newly Diagnosed, High-Risk, Early-Stage Triple-Negative Breast Cancer (MK-5890-003) Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of adding boserolimab (MK-5890), an experimental immunotherapy, to standard of care treatment before surgery (neoadjuvant) for triple negative breast cancer (TNBC).
Who is this for?
People with stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Boserolimab, by IV, every 6 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Boserolimab, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV</li> </ul> <p class="seamTextPara"> followed by after surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 7.5 months</li> <li class="seamTextUnorderedListItem">Additional treatment (optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV</li> </ul> <p class="seamTextPara"> followed by after surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 7.5 months</li> <li class="seamTextUnorderedListItem">Additional treatment (optional)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Boserolimab (MK-5890) is an experimental immunotherapy that may boost the function of immune cells to find and kill cancer cells by activating a molecule called CD27.</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">Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are chemotherapy drugs that stop tumor cells from growing and dividing and may kill them.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06829199' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/boserolimab' target='_blank'>National Cancer Institute: Boserolimab</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/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
36
NEAREST SITE: 533 miles
OHSU Knight Cancer Institute
Portland,OR
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT05768932
BAL0891 Targeted Therapy Alone or With Chemotherapy for Advanced Triple Negative Breast Cancer
A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of BAL0891, an experimental TTK/PLK inhibitor, alone or with chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or ER low, HER2- or HER2 low) breast cancer who have received at least 1 line of therapy for advanced disease. You must not have received more than 4 lines of chemotherapy.
Full eligibility criteria
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- What's being studied?
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-
<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891 is an experimental targeted therapy called a TTK/PLK inhibitor. Blocking TTK/PLK may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/FISH-.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05768932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.sillajen.com/eng/sub/pipeline_bal0891.html' target='_blank'>SillaJen: BAL0891 Drug Information Page</a> </li></ul>
37
NEAREST SITE: 602 miles
Huntsman Cancer Institute
Salt Lake City,UT
VISITS: 5 visits a month, ongoing
PHASE: I
NCT ID: NCT04315233
Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer
A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE) Scientific Title
Purpose
To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor ribociclib (Kisqali®) in combination with the chemotherapy belinostat (Beleodaq®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a CDK 4/6 inhibitor.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®), by IV, 5 days in a row (1 week on, 3 weeks off), ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor--it blocks two enzymes, CDK4 and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Ribociclib is approved for use in combination with an aromatase inhibitor to treat postmenopausal women with advanced hormone positive, HER2 negative breast cancer--but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®) is a type of chemotherapy called an histone deacetylase (HDAC) inhibitor. It is approved for use in some other types of 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 cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04315233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/belinostat.aspx' target='_blank'>Chemocare.com: Belinostat (Beleodaq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617008.html' target='_blank'>MedLinePlus: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>
38
NEAREST SITE: 679 miles
Swedish Cancer Institute
Issaquah,WA
VISITS: 1 visit every 1-2 weeks
PHASE: II
NCT ID: NCT05458674
Targeted Therapy and Chemotherapy for Advanced HER2+ Breast Cancer
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 Scientific Title
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.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
39
NEAREST SITE: 682 miles
Fred Hutchinson Cancer Center
Seattle,WA
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT04969835
AVA6000 Chemotherapy for Advanced Breast Cancer
A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of AVA6000, an experimental chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received standard treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVA6000, by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVA6000 is an experimental form of doxorubicin chemotherapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04969835' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avacta.com/therapeutics/precision/' target='_blank'>Avacta Life Sciences: AVA6000 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
40
NEAREST SITE: 1388 miles
Oklahoma University
Oklahoma City,OK
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05867251
ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer
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 Scientific Title
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.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li></ul>
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<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>
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<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>
41
NEAREST SITE: 1418 miles
University of Nebraska Medical Center
Omaha,NE
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04222062
Local Chemotherapy to Prevent a Recurrence of Brain Metastases After Surgery
A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease Scientific Title
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.
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Gliadel</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard care</i> </p> <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>
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<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>
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<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>
42
NEAREST SITE: 1454 miles
Altru Cancer Center
Grand Forks,ND
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05969860
Chemotherapy Treatment At Home for People with Advanced Breast Cancer
Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic Scientific Title
Purpose
To compare the safety and effects (good and bad) of receiving paclitaxel (Taxol®) chemotherapy at home and at a clinic.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who are receiving chemotherapy, trastuzumab (Herceptin®), leuprolide (Lupron®), or goserelin (Zoladex®). You must live within 35 miles from Mayo Clinic in Jacksonville, FL.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Treatment At Home</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive paclitaxel (Taxol®) chemotherapy at home, 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Treatment At Clinic and Home</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive paclitaxel (Taxol®) chemotherapy at clinic, 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive paclitaxel (Taxol®) chemotherapy at home, 4 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Providing cancer treatment at home, versus in the clinic, may help reduce mental and financial distress and increase treatment compliance, especially for marginalized patients and communities.</li> <li class="seamTextUnorderedListItem">Home health appointments include chemotherapy administration, routine vital sign monitoring, and routine lab tests.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05969860' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/medical-professionals/cancer/news/high-quality-advanced-cancer-care-conducted-at-home/mac-20538184' target='_blank'>Mayo Clinic: Cancer CARE Beyond Walls</a> </li></ul>
43
NEAREST SITE: 1478 miles
Texas Oncology- San Antonio
San Antonio,TX
VISITS: 1 visit every month
PHASE: II
NCT ID: NCT05748834
Tucatinib Targeted Therapy and Doxil Chemotherapy for Advanced HER2+ Breast Cancer
Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer Scientific Title
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.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, monthly</li></ul>
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<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>
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<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>
44
NEAREST SITE: 1481 miles
The University of Texas Health Science Center at San Antonio
San Antonio,TX
VISITS: 1-5 visits every month
PHASE: I
NCT ID: NCT05029999
2 Immunotherapies and Chemotherapy for Advanced Triple Negative Breast Cancer
Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of CDX-301 and CDX-1140, two experimental types of immunotherapy, with chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer and have received 0-2 lines of therapy for advanced disease. You must not have received treatment with Adriamycin® (doxorubicin) or Doxil® (doxorubicin) chemotherapy for advanced disease.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month, starting month 2</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month, starting month 2</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 2 biopsies</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301 and CDX-1140 are experimental types of immunotherapy that allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">CDX-301 increases immune cells and CDX-1140 activates immune cells that are needed to kickstart the immune response.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a type of chemotherapy drug. It trains immune cells to recognize the cancer for the immune system to attack it.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05029999' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://celldex.com/pipeline/overview/' target='_blank'>Celldex Therapeutics Drug Information Page: CDX-1140</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-cdx-1140' target='_blank'>National Cancer Institute: CDX-1140</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.celldex.com/news-releases/news-release-details/celldex-therapeutics-cdx-301-safely-mobilizes-hematopoietic' target='_blank'>Celldex Therapeutics Press Release: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/doxil' target='_blank'>Breastcancer.org: Doxorubicin (Doxil®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
45
NEAREST SITE: 1482 miles
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas,TX
VISITS: Number of visits unavailable, ongoing
PHASE: I
NCT ID: NCT04265872
Bortezomib, Pembrolizumab and Cisplatin for Women with Metastatic Triple Negative or ER Low Breast Cancer
Pilot Clinical Trial of Treatment With Bortezomib to Inhibit Homologous Recombination (HR) Followed by Pembrolizumab and Cisplatin in Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer Scientific Title
Purpose
To study the anti-cancer activity, safety, and side effects of first giving bortezomib (Velcade®), then giving pembrolizumab (Keytruda®) and cisplatin (Platinol®).
Who is this for?
Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer who have not received more than three chemotherapies for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®), by IV</li> <li class="seamTextUnorderedListItem">followed by, pembrolizumab (Keytruda®) and cisplatin (Platinol®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
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<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 women with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®) is a type of targeted therapy called a protease inhibitor. It is approved for use in some other cancers but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved for use in some cancers but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) is a platinum-based chemotherapy commonly used for metastatic triple negative breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04265872' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Bortezomib' target='_blank'>Wikipedia: Bortezomib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.velcade.com/about-velcade/faq' target='_blank'>Takeda Pharmaceutical Company Drug Information Page: Velcade® (Bortezomib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/meetingcoverage/asco/86804' target='_blank'>MedPage Today: Pembrolizumab May Help in Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncobites.blog/2020/02/07/cisplatin-a-journey-to-a-solution-for-triple-negative-breast-cancer/' target='_blank'>OncoBites Blog: Cisplatin--A Journey to a Solution for Triple-Negative Breast Cancer</a> </li></ul>
46
NEAREST SITE: 1499 miles
The University of Kansas Cancer Center - Overland Park
Overland Park,KS
VISITS: 1 visit every 2-3 weeks for 3-4.5 months
PHASE: II
NCT ID: NCT05645380
Chemoimmunotherapy Before Surgery for Women with Stage I-III Triple Negative Breast Cancer
Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC Scientific Title
Purpose
To study if the number of immune cells in and around tumors impacts tumor response to neoadjuvant (before surgery) chemoimmunotherapy and can be used to personalize the type and amount of neoadjuvant chemoimmunotherapy.
Who is this for?
Women 18-70 years old with stage I, stage II, or some stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on your situation: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: High/Intermediate Number of Immune Cells</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for 3-4.5 months</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks for 3-4.5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 3 weeks for 3-4.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Low Number of Immune Cells</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 3 weeks for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2-3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2-3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 2-3 weeks for 3 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemoimmunotherapy is chemotherapy combined with immunotherapy.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), docetaxel (Taxotere®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs commonly used to treat 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">Triple negative breast cancer (TNBC) with more immune system cells in and around the tumor are more sensitive to chemoimmunotherapy and have better outcomes.</li> <li class="seamTextUnorderedListItem">Imaging is often used during the course of neoadjuvant chemoimmunotherapy to monitor how the disease is responding to treatment.</li> <li class="seamTextUnorderedListItem">Tumor disappearance seen by imaging scans after chemoimmunotherapy usually means that the tumor will have completely disappeared by surgery.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05645380' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/search?search=carboplatin' target='_blank'>Breastcancer.org: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxotere' target='_blank'>Breastcancer.org: Docetaxel (Taxotere®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/adriamycin' target='_blank'>Breastcancer.org: Doxorubicin (Adriamycin®)</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://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
47
NEAREST SITE: 1509 miles
UT Southwestern Medical Center
Dallas,TX
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05693766
Hormone Therapy or Chemotherapy with Genetic Testing for Metastatic HR+, HER2- Breast Cancer
Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT) Scientific Title
Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy and capecitabine (Xeloda®) chemotherapy and use MammaPrint® and BluePrint tests to guide treatment decisions.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), non-Luminal A breast cancer who have received treatment with an aromatase inhibitor or selective estrogen receptor modulator/downregulator (SERM/SERD) with a CDK4/6 inhibitor. You must not have received chemotherapy or more than 1 line of hormone therapy for advanced disease or have a PIK3CA mutation.
Full eligibility criteria
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- What's being studied?
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<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">Physician's choice of hormone therapy</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 1 week on, 1 week off</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">MammaPrint® and BluePrint are genetic tests that use tumor samples to help guide treatment decisions.</li> <li class="seamTextUnorderedListItem">The tests will also be used to determine if certain mutations are potentially associated with resistance to therapy.</li> <li class="seamTextUnorderedListItem">Luminal A breast cancer is ER+, PR+, and HER2- with low Ki-67 levels, which controls how fast cancer cells grow. Luminal A cancers tend to grow more slowly.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05693766' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/molecular-subtypes' target='_blank'>Breastcancer.org: Molecular Subtypes of Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing' target='_blank'>Breastcancer.org: Genetic Testing for Breast Cancer</a> </li></ul>
48
NEAREST SITE: 1591 miles
Cox Medical Center
Springfield,MO
VISITS: 1 visit every 3 weeks, ongoing
PHASE: III
NCT ID: NCT03671044
Comparing an Experimental form of Docetaxel to Standard Docetaxel in Women with Advanced Triple Negative Breast Cancer
A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy Scientific Title
Purpose
To compare the safety and anti-cancer activity of Nanosomal Docetaxel Lipid Suspension (NDLS) to docetaxel (Taxotere®).
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have received no more than one chemotherapy for metastatic disease.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nanosomal Docetaxel Lipid Suspension (NDLS), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) is a chemotherapy commonly used for breast cancer.</li> <li class="seamTextUnorderedListItem">Nanosomal Docetaxel Lipid Suspension (NDLS) is an experimental form of docetaxel. </li> <li class="seamTextUnorderedListItem">Research suggests that NDLS is safer than the standard form of docetaxel.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03671044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/docetaxel-taxotere' target='_blank'>Breast Cancer Now: Docetaxel</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/nanosomal-docetaxel-lipid-suspension' target='_blank'>NCI Drug Dictionary: Nanosomal Docetaxel Lipid Suspension</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/28255844/' target='_blank'>Journal Abstract: Nanosomal Docetaxel Lipid Suspension</a> </li></ul>
49
NEAREST SITE: 1621 miles
MD Anderson in The Woodlands
Conroe,TX
VISITS: Coincides with routine care
PHASE: NA
NCT ID: NCT02276443
Tumor Testing Before Treatment for Stage I-III Triple Negative Breast Cancer
Improving Outcomes in Triple-Negative Breast Cancer Using Molecular Triaging and Diagnostic Imaging to Guide Neoadjuvant Therapy ARTEMIS MDACC Breast Moonshot Initiative) Scientific Title
Purpose
To study if tumor testing before treatment improves treatment response.
Who is this for?
People with newly diagnosed stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have not yet received treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarker and molecular tumor testing</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Ultrasound, 4 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your choice of standard of care treatment or clinical trial based on testing results</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Studies suggest molecular testing of tumors can help guide treatment options.</li> <li class="seamTextUnorderedListItem">This study will compare tumor response of women whose treatment is guided by tumor testing results to those of women whose treatment is chosen without tumor testing.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02276443' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2014-0185.html' target='_blank'>MD Anderson Cancer Center: ARTEMIS Trial Information Page</a> </li></ul>
50
NEAREST SITE: 1643 miles
Houston Methodist Cancer Center
Houston,TX
VISITS: Please contact research site
PHASE: I
NCT ID: NCT03742245
PARP Inhibitor Olaparib and the Chemotherapy Vorinostat for Advanced HER2 Negative Breast Cancer
Multicenter Phase I/Ib Trial of Olaparib in Combination With Vorinostat in Patients With Relapsed/Refractory and/or Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, dose, and anti-cancer activity of giving a PARP inhibitor in combination with chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®), by mouth, daily, ongoing</li></ul>
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<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">Olaparib is approved to treat metastatic HER2 negative breast cancer in people with a BRCA 1/2 genetic (inherited) mutation. However, the use of olaparib in this trial is considered investigational. </li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®) is chemotherapy approved to treat a type of cancer called T-cell lymphoma. Its use in this trial is considered investigational.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742245' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/lynparza' target='_blank'>Breastcancer.org: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Vorinostat.aspx' target='_blank'>Chemocare: Vorinostat</a> </li></ul>
51
NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05092373
Tumor Treating Fields Device for Advanced Breast Cancer
Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib, or With Atezolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of Tumor Treating Fields (TTF), an experimental wearable device, with targeted therapy or chemotherapy and immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on your type of cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: TTF with Targeted Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF), daily</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx® or Cometriq®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: TTF with Chemotherapy and Immunotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF), daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF) consists of experimental wearable devices that use electrical fields at different frequencies to stop the growth of tumor cells by interrupting cancer cells' ability to divide.</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx® or Cometriq®) is a type of targeted therapy called a tyrosine kinase inhibitor. Tyrosine kinase inhibitors work by blocking proteins that signal cancer cells to multiply, which may help keep cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) 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">Nab-paclitaxel (Abraxane®) is a type of chemotherapy drug.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05092373' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/tumor-treating-fields-ttf-4584149' target='_blank'>Verywell Health: Tumor Treating Fields (TTF)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a616037.html' target='_blank'>MedlinePlus: Cabozantinib (Cabometyx® or Cometriq®)</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://www.breastcancer.org/treatment/immunotherapy/tecentriq' target='_blank'>Breastcancer.org: Atezolizumab (Tecentriq®)</a> </li></ul>
52
NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT06318897
Pembrolizumab Immunotherapy with Chemotherapy Before Surgery for Stage I Triple Negative Breast Cancer
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) pembrolizumab (Keytruda®) PD-1 inhibitor with carboplatin (Paraplatin®) and paclitaxel (Taxol®) chemotherapies.
Who is this for?
People with some stage I triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have not yet received surgery.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> </ul> <p class="seamTextPara"> You will then be assigned to 1 of 2 groups based on your response to treatment: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: No Cancer Detected After Neoadjuvant Treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Cancer Detected After Neoadjuvant Treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxin®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>
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<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">Carboplatin (Paraplatin®), paclitaxel (Taxol®), doxorubicin (Doxil®), and cyclophosphamide (Cytoxin®) are chemotherapy drugs.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06318897' target='_blank'>ClinicalTrials.gov</a> </li></ul>
53
NEAREST SITE: 1643 miles
Houston Methodist Neal Cancer Center
Houston,TX
VISITS: 2 visits every 3 weeks
PHASE: II
NCT ID: NCT05660083
Targeted Therapy and Chemotherapy for Advanced Triple Negative or Metaplastic HER2 Negative Breast Cancer
Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC) Scientific Title
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®).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
54
NEAREST SITE: 1678 miles
University of Wisconsin Carbone Cancer Center
Madison,WI
VISITS: Weekly visits for 3 months
PHASE: IV
NCT ID: NCT03096418
Taxol Before Surgery for Stage I-III Breast Cancer
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response Scientific Title
Purpose
To study the effects (good and bad) that the chemotherapy paclitaxel (Taxol®) has on the tumor.
Who is this for?
Women with stage I, stage II, or stage III breast cancer who have not yet had breast surgery or any other treatment for their cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for up to 3 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A chemotherapy will be given before surgery (neoadjuvant treatment).</li> <li class="seamTextUnorderedListItem">Giving chemotherapy before surgery can shrink the tumor.</li> <li class="seamTextUnorderedListItem">It also lets researchers study whether the drug works better for certain types of tumors.</li> <li class="seamTextUnorderedListItem">The chemotherapy being used in this study is paclitaxel (Taxol®). It is commonly used to treat breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03096418' target='_blank'>ClinicalTrials.gov</a> </li></ul>
55
NEAREST SITE: 1739 miles
Washington University School of Medicine
Saint Louis,MO
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05837455
Biomarkers to Guide Therapy Before Surgery for Stage II-III ER+, HER2- Breast Cancer
NeoTAILOR: A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer Scientific Title
Purpose
To study the effects (good and bad) of whether a novel biomarker-driven approach can be used to guide selection of treatment before surgery (neoadjuvant).
Who is this for?
Postmenopausal women with newly diagnosed stage II or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Biomarker tests</li> <li class="seamTextUnorderedListItem">Surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Biomarker tests</li> <li class="seamTextUnorderedListItem">Surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Biomarker tests</li> <li class="seamTextUnorderedListItem">Chemotherapy with an anthracycline drug, by IV, and/or a taxane, by IV, for up to 6 months</li> <li class="seamTextUnorderedListItem">Surgery</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarkers are genes, molecules, or other features present in a person that tell doctors something about that person’s health.</li> <li class="seamTextUnorderedListItem">Using biomarkers to select treatment may improve the clinical response and identify those who may not require chemotherapy before surgery (neoadjuvant).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05837455' target='_blank'>ClinicalTrials.gov</a> </li></ul>
56
NEAREST SITE: 1739 miles
Washington University School of Medicine
Saint Louis,MO
VISITS: Weekly for 3 weeks, then 1 visit every 3 weeks
PHASE: I-II
NCT ID: NCT06374459
Zunsemetinib Targeted Therapy with Chemotherapy for Metastatic HR+, HER2- Breast Cancer with Bone 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 Bone Metastasis Scientific Title
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 bone (bone 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.
Full eligibility criteria
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<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>
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<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 bone loss.</li> <li class="seamTextUnorderedListItem">Bisphosphonate (zoledronic acid) and denosumab are standard of care drugs that help strengthen bones but have little effect on pain relief and anti-cancer activity.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</li></ul>
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<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>
57
NEAREST SITE: 1814 miles
The West Clinic
Germantown,TN
VISITS: At least 1 visit every 3 weeks
PHASE: I-II
NCT ID: NCT03424005
Atezolizumab & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer
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) Scientific Title
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.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 7 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 7</i> </p> <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>
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<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>
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<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>
58
NEAREST SITE: 1853 miles
University of Illinois
Chicago,IL
VISITS: 1 visit every 3 weeks for 6 months
PHASE: II
NCT ID: NCT06085742
Oral CMC Chemotherapy After Surgery for Stage I-III HR+, HER2- Breast Cancer
BRE-08: A Phase II Study of an All-Oral Adjuvant Chemotherapy Regimen of Cyclophosphamide, Methotrexate, and Capecitabine (CMC) for Early-Stage Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of CMC chemotherapy taken orally (by mouth): cyclophosphamide (Cytoxan®), methotrexate (Otrexup®), and capecitabine (Xeloda®).
Who is this for?
People with stage I, stage II, or some stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to receive chemotherapy after surgery. Your breast cancer must be considered high risk on MammaPrint/BluePrint or have an Oncotype Recurrence Score of 26 or higher.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Methotrexate (Otrexup®), by mouth, weekly for 6 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, weekly, 2 weeks on, 1 week off, for 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), methotrexate (Otrexup®), and capecitabine (Xeloda®) are chemotherapy medications commonly used to treat breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06085742' target='_blank'>ClinicalTrials.gov</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://www.breastcancer.org/drugs/methotrexate' target='_blank'>Breastcancer.org: Methotrexate (Otrexup®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>
59
NEAREST SITE: 1853 miles
University of Illinois
Chicago,IL
VISITS: 1 visit every 3 weeks
PHASE: II
NCT ID: NCT06441890
Biomarker Tests to Plan Treatment Before Surgery for Stage I-III HER2+ Breast Cancer
BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE Trial Scientific Title
Purpose
To use the MammaPrint® and/or BluePrint® tests to determine who should receive neoadjuvant (before surgery) chemotherapy.
Who is this for?
People with newly diagnosed stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who have not yet received treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MammaPrint® and/or BluePrint® tests</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 3 weeks (if needed based on test results)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MammaPrint® and BluePrint® are genetic tests that use tumor samples to help guide treatment decisions and determine risk of recurrence (cancer coming back).</li> <li class="seamTextUnorderedListItem">In this trial, you may receive at least 1 of the following chemotherapy drugs: nab-paclitaxel (Abraxane®), paclitaxel (Taxol®), docetaxel (Taxotere®), pertuzumab (Perjeta®), trastuzumab (Herceptin®).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06441890' target='_blank'>ClinicalTrials.gov</a> </li></ul>
60
NEAREST SITE: 1853 miles
University of Illinois Cancer Center
Chicago,IL
VISITS: At least 5 visits over 1 month
PHASE: II
NCT ID: NCT04891068
Experimental Chemotherapy Before Surgery Plus Standard of Care for Women with High-Risk Stage I-II Breast Cancer
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer Scientific Title
Purpose
To study the safety, dose, anti-cancer activity, and the effects on the immune system of giving a low dose of an experimental chemotherapy before surgery.
Who is this for?
Women with stage I or stage II breast cancer that is considered high-risk for recurrence. See below for this trial's definition of high-risk.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azacitidine, by injection, daily, for 5 days in a row</li> <li class="seamTextUnorderedListItem">followed by the standard of care for your stage and subtype of breast cancer</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial defines high-risk breast cancer as having a primary tumor greater than 1 cm, and the cancer is:</li> <li class="seamTextUnorderedListItem">Triple-negative (ER-, PR-, HER2-), or</li> <li class="seamTextUnorderedListItem">Estrogen-receptor positive and either HER2-positive, node-positive, progesterone-receptor negative, or has a clinical high expression on the MammaPrint, Oncotype, or Endopredict test. </li> <li class="seamTextUnorderedListItem">Azacitidine is a chemotherapy approved for use in other diseases, but its use in breast cancer is considered experimental.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04891068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a607068.html' target='_blank'>MedLinePlus: Azacitidine</a> </li></ul>
61
NEAREST SITE: 1856 miles
Northwestern University
Chicago,IL
VISITS: 1 visit every 3 weeks, ongoing
PHASE: II
NCT ID: NCT03213041
Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer
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) Scientific Title
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.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
62
NEAREST SITE: 1944 miles
IU Health Joe and Shelly Schwarz Cancer Center
Carmel,IN
VISITS: 1-2 visits every month
PHASE: II
NCT ID: NCT05846789
Chemotherapy Alone or With Immunotherapy for Advanced Triple Negative, PD-L1 Negative Breast Cancer
A Phase II Trial of Carboplatin +/- Tocilizumab as Initial Therapy for Metastatic Triple Negative and ER-low Breast Cancers Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of carboplatin (Paraplatin®) chemotherapy alone or with tocilizumab, an experimental immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR-, HER2- or HER2 low), PD-L1 negative breast cancer who have not received chemotherapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tocilizumab, by IV, monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Tocilizumab is an experimental immunotherapy called an IL-6 inhibitor that is approved to treat arthritis. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ and FISH-.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05846789' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/carboplatin' target='_blank'>Breastcancer.org: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a611004.html' target='_blank'>MedlinePlus: Tocilizumab</a> </li></ul>
63
NEAREST SITE: 1946 miles
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis,IN
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT04711824
Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases
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 Scientific Title
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.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <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> <p class="seamTextPara"> followed by: </p> <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>
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<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>
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<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>
64
NEAREST SITE: 1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville,TN
VISITS: Coincides with routine care
PHASE: II
NCT ID: NCT05770531
ctDNA Tests to Support Treatment Decisions for People with Metastatic Triple Negative, PD-L1 Negative Breast Cancer
A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer Scientific Title
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.
Full eligibility criteria
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<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">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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <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> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to sacituzumab govitecan (Trodelvy®), by IV (depending on blood test results)</li></ul>
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<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>
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<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>
65
NEAREST SITE: 1961 miles
Vanderbilt Breast Center at One Hundred Oaks
Nashville,TN
VISITS: 1 visit every 1-2 weeks
PHASE: I
NCT ID: NCT05422794
ZEN-3694 Targeted Therapy with Chemotherapy and Immunotherapy for Advanced Triple Negative Breast Cancer that is PD-L1 Negative
A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic Triple-Negative Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ZEN-3694, an experimental BET inhibitor, with nab-paclitaxel (Abraxane®) chemotherapy and 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 that is PD-L1 negative who have received 0-1 lines of therapy for advanced or metastatic disease. You must not have received PD-1/PD-L1 inhibitors, nab-paclitaxel (Abraxane®), paclitaxel (Taxol®), or docetaxel (Taxotere®) for advanced or metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN-3694, by mouth, daily, 1 week</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN-3694, by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT or MRI scans</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN-3694 is an experimental targeted therapy called a BET inhibitor. Blocking BET may help slow or stop the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug commonly used to treat 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">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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05422794' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zenithepigenetics.com/programs/pipeline' target='_blank'>Zenith Epigenetics Drug Information Page: ZEN-3694</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://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
66
NEAREST SITE: 2013 miles
University of Alabama at Birmingham
Birmingham,AL
VISITS: At least 2 times in 3 months
PHASE: II
NCT ID: NCT06105684
Low Dose Capecitabine Chemotherapy for People with Advanced HR+, HER2- or Triple Negative Breast Cancer
Phase II Single Arm Trial of Low Dose Capecitabine in Patients with Advanced Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of a lower dose of capecitabine (Xeloda®) chemotherapy for older or frail (weak) people with advanced breast cancer.
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-, PR-, HER2- or HER2 low) breast cancer who have received at least 1 line of therapy for advanced disease. You must be frail (weak) or at least 60 years old.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Low dose capecitabine (Xeloda®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In this trial, frail is defined as having a greater risk of complications and poorer outcomes because of illness, injury, or age.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">A lower dose of capecitabine (Xeloda®) may be better for frail and older people.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06105684' target='_blank'>ClinicalTrials.gov</a> </li></ul>
67
NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH
VISITS: May require hospitalization; 4-7 visits every month
PHASE: I-II
NCT ID: NCT06026657
Gemcitabine Chemotherapy and NK Cell Therapy for Metastatic HER2 Negative Breast Cancer
Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of gemcitabine (Gemzar®) chemotherapy and NK cell therapy with or without naxitamab (Danyelza®) targeted therapy.
Who is this for?
People with stage IV (metastatic) HER2 negative (HER2-) breast cancer who have received at least 1 line of therapy for metastatic disease.
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, monthly, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, 2 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, monthly, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, 2 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy drug that blocks cancer cells from making DNA which may kill cancer cells.</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®) is a type of targeted therapy called a GD2 inhibitor. GD2 inhibitors help your immune system attack tumor cells.</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®) is approved to treat people with other types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy is an experimental immunotherapy. NK cells are part of your natural immune system and can identify cancer cells and help your immune system kill cancer cells.</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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06026657' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/gemzar' target='_blank'>Breastcancer.org: Gemcitabine (Gemzar®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a621005.html#:~:text=Naxitamab%2Dgqgk%20injection%20is%20used,have%20responded%20to%20other%20treatments.' target='_blank'>Medline Plus: Naxitamab (Danyelza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/body/24898-natural-killer-cells' target='_blank'>Cleveland Clinic: NK Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>
68
NEAREST SITE: 2139 miles
Emory University Winship Cancer Institute
Atlanta,GA
VISITS: At least 1 visit every 1-2 weeks
PHASE: I-II
NCT ID: NCT06460298
ProAgio Targeted Therapy with Chemotherapy for Advanced Triple Negative Breast Cancer
Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of ProAgio, an experimental targeted therapy, with gemcitabine (Gemzar®) chemotherapy.
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-) breast cancer who have received at least 2 lines of therapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ProAgio, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ProAgio is an experimental targeted therapy called an αVβ₃ inhibitor. αVβ₃ inhibitors may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy drug.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06460298' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://research.gsu.edu/startup/proda-biotech/' target='_blank'>Georgia State University: ProAgio</a> </li></ul>
69
NEAREST SITE: 2299 miles
Levine Cancer Institute
Charlotte,NC
VISITS: 1 visit every 1-2 weeks
PHASE: II
NCT ID: NCT06027268
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) Scientific Title
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.
Full eligibility criteria
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<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>
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<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 bone marrow from the side effects of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
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<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>
70
NEAREST SITE: 2314 miles
Wake Forest Baptist Health Sciences
Winston-Salem,NC
VISITS: 1 visit every 1-3 weeks for up to 5 months
PHASE: II
NCT ID: NCT04677816
Vitamin D with Chemotherapy Before Surgery for People with Triple Negative Breast Cancer
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of vitamin D with standard of care doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), and paclitaxel (Taxol®) neoadjuvant (before surgery) chemotherapy.
Who is this for?
People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who are receiving or planning to receive chemotherapy before surgery (neoadjuvant).
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental for People With Vitamin D Deficiency</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for up to 5 months</li> <li class="seamTextUnorderedListItem">Vitamin D3, by mouth, weekly for 5 months</li> <li class="seamTextUnorderedListItem">Drug diary</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care for People Without Vitamin D Deficiency</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for up to 5 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), and paclitaxel (Taxol®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies. </li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04677816' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/diet-nutrition/dietary-supplements/known/vitamin-d' target='_blank'>Breastcancer.org: Vitamin D and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/integrative-medicine/herbs/vitamin-d#:~:text=A%20meta%2Danalysis%20of%20vitamin,supportive%20hazard%20ratio%20(90).' target='_blank'>Mayo Clinic: Vitamin D</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
71
NEAREST SITE: 2314 miles
Comprehensive Cancer Center at Wake Forest University (CCCWFU)
Winston-Salem,NC
VISITS: 1 visit every 2 weeks, ongoing
PHASE: II
NCT ID: NCT02422641
Methotrexate in Metastatic Breast Cancer With Leptomeningeal Metastasis
Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail Scientific Title
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).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">High-dose Methotrexate (HD-MTX), by IV, once every 2 weeks</li></ul>
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<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>
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<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>
72
NEAREST SITE: 2351 miles
University of Florida
Gainesville,FL
VISITS: 1 visit every 1-3 weeks for 3 months
PHASE: I-II
NCT ID: NCT05074290
Epidiferphane Nutritional Supplement with Chemotherapy for Stage I-IV Breast Cancer
Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of epidiferphane, an experimental nutritional supplement, with chemotherapy.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning on receiving treatment with chemotherapy.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Epidiferphane, by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: Docetaxel (Taxotere®), every 3 weeks; paclitaxel (Taxol®), weekly; or nab-paclitaxel (Abraxane®), weekly; 3 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Epidiferphane is an experimental nutritional supplement that may reduce chemotherapy symptoms.</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), paclitaxel (Taxol®), and nab-paclitaxel (Abraxane®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with lobular breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05074290' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/epidiferphane' target='_blank'>National Cancer Institute: Epidiferphane</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
73
NEAREST SITE: 2352 miles
University of Rochester
Rochester,NY
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04965064
Neratinib Targeted Therapy with Capecitabine Chemotherapy for Metastatic HER2 Negative Breast Cancer with Abnormally Active HER2 Signaling and Brain Metastases
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 Scientific Title
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).
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
74
NEAREST SITE: 2371 miles
University of Virginia
Charlottesville,VA
VISITS: 1-2 visits within 8 days
PHASE: I
NCT ID: NCT04796220
Thermal Treatment and Chemotherapy Before Surgery for Stage I-III Breast Cancer
Focused Ultrasound With Low-Dose Gemcitabine to Augment Immune Control of Early Stage Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of EchoPulse ultrasound ablation and gemcitabine (Gemzar®) chemotherapy alone or together before surgery (neoadjuvant).
Who is this for?
People with newly diagnosed stage I, stage II, or stage III breast cancer who have not yet received treatment.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 1 time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EchoPulse ultrasound ablation of tumor, 1 time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 1 time</li> <li class="seamTextUnorderedListItem">EchoPulse ultrasound ablation of tumor, 1 time</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EchoPulse ultrasound ablation applies high-intensity focused ultrasound waves to a tumor, which ablates (heats) the tumor tissue to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a type of chemotherapy that kills cancer cells.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04796220' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.theraclion.com/products/echopulse/' target='_blank'>Theraclion: EchoPulse Ultrasound Ablation</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/treatments/16541-hifu-high-intensity-focused-ultrasound' target='_blank'>Cleveland Clinic: High-Intensity Focused Ultrasound</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/gemzar' target='_blank'>Breastcancer.org: Gemcitabine (Gemzar®)</a> </li></ul>
75
NEAREST SITE: 2371 miles
University of Virginia
Charlottesville,VA
VISITS: Number of visits unavailable
PHASE: II-III
NCT ID: NCT05288777
Radiation with ADC or Chemotherapy for Stage I-III Breast Cancer with Residual Disease
A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of external beam radiation therapy with trastuzumab emtansine (T-DM1, Kadcyla®) antibody drug conjugate (ADC) or capecitabine (Xeloda®) chemotherapy.
Who is this for?
People with stage I, stage II, or some stage III breast cancer who have residual disease after completing neoadjuvant (before surgery) chemotherapy and receiving a lumpectomy and/or mastectomy.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: HER2 Positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">External beam radiation therapy, 2-3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®), by IV, every 3 weeks for 10 months</li> <li class="seamTextUnorderedListItem">Surveys</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2 Negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">External beam radiation therapy, 2-3 weeks</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), daily for 6 months</li> <li class="seamTextUnorderedListItem">Surveys</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells that are present after treatment.</li> <li class="seamTextUnorderedListItem">External beam radiation therapy (EBRT) is the most common type of radiation.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1) is 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">Trastuzumab emtansine (Kadcyla®, T-DM1)'s antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called emtansine.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05288777' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/treatments/24008-external-beam-radiation-therapy-ebrt' target='_blank'>Cleveland Clinic: External Beam Radiation Therapy (EBRT)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine (T-DM1, Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>
76
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: 1 visit every week
PHASE: II
NCT ID: NCT05325632
Dendritic Cell Vaccine With Neoadjuvant Therapy for HER2 Positive Breast Cancer
A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine, an experimental immunotherapy, with targeted therapy and chemotherapy before surgery (neoadjuvant).
Who is this for?
People with stage I, stage II, or some stage III HER2 positive (HER2+) breast cancer who have not received surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, weekly for 6 weeks, then 3 times within 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 5 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 5 months</li> </ul> <p class="seamTextPara"> followed 2 months later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Abraxane®), by IV, weekly for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after HER2+ cancer cells, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are types of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Abraxane®) is a chemotherapy drug commonly used for breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like hormone therapy or targeted therapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05325632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancerorg: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancerorg: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancerorg: Pertuzumab (Perjeta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancerorg: Paclitaxel (Abraxane®)</a> </li></ul>
77
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT06409390
Studying a New Order of Giving Currently Approved Drugs for Women with HR+, HER2- Breast Cancer
A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer Scientific Title
Purpose
To study a new order of giving currently approved drugs to treat metastatic breast cancer.
Who is this for?
Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received an aromatase inhibitor or tamoxifen (Nolvadex®).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) or trastuzumab deruxtecan (Enhertu®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) or abemaciclib (Verzenio®)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are continually developing new drugs to treat metastatic breast cancer (MBC) and understanding how to best use drugs already approved for MBC.</li> <li class="seamTextUnorderedListItem">An important question in treatment planning is the order in which drugs are given, called “drug sequencing”.</li> <li class="seamTextUnorderedListItem">All drugs in this trial are approved for metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), docetaxel (Taxotere®), and capecitabine (Xeloda®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) and trastuzumab deruxtecan (Enhertu®) are types of targeted therapy called antibody drug conjugates (ADC).</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) and abemaciclib (Verzenio®) are types of targeted therapy called CDK4/6 inhibitors.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06409390' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/drug-sequencing/?utm_medium=email&utm_source=subscribers&utm_campaign=Mar2024&utm_content=Email032024' target='_blank'>Metastatic Trial Talk: What is “Drug Sequencing”?</a> </li></ul>
78
NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD
VISITS: Requires hospitalization for 3-4 weeks
PHASE: I
NCT ID: NCT06253520
T Cell Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations
A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of an experimental T cell therapy using a person's own modified white blood cells with an experimental vaccine.
Who is this for?
People with stage IV (metastatic) breast cancer with a KRAS mutation who have received at least 2 lines of therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 days</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 days</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 1-4 days</li> <li class="seamTextUnorderedListItem">T cells, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Vaccine, by injection, 3-4 times</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Many cancer cells produce substances (antigens) that are unique to each cancer and stimulate the body's immune responses.</li> <li class="seamTextUnorderedListItem">Taking disease-fighting white blood cells (T cells) from a person, changing those cells so they will target the specific proteins (antigens) from the cancer cells, and returning them to that person's blood is a form of gene therapy.</li> <li class="seamTextUnorderedListItem">A vaccine may help these modified white cells work better.</li> <li class="seamTextUnorderedListItem">Leukapheresis is when blood is removed from the body, white blood cells are separated, and the remaining blood is returned to the body.</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®) and cyclophosphamide (Cytoxan®) are chemotherapy drugs that make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin is a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>
79
NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD
VISITS: Hospital stay for up to 9 days; screening test every few months for 2 years
PHASE: II
NCT ID: NCT03412877
Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer Scientific Title
Purpose
To study the safety and effects (good and bad) of an immunotherapy that uses personalized T cells.
Who is this for?
People with metastatic (stage IV) breast cancer for which standard treatments have not worked.
Full eligibility criteria
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<p class="seamTextPara"> You will be in the hospital and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Before hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells), 2-4 months before receiving treatment</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay for receiving treatment (2-3 weeks):</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, once a day, for 2 days </li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara), by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Followed by Aldesleukin, by IV, once every 8 hours, for up to 4 days </li> <li class="seamTextUnorderedListItem">TCR-Transduced T-Cells, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">After hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic and antiviral, for at least 6 months</li> <li class="seamTextUnorderedListItem">Screening tests, every few months for the first year, every 6 months for the second year, then as determined</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To create the personalized T cells, cancer cells will be taken from your tumor and white blood cells will be removed from your blood. </li> <li class="seamTextUnorderedListItem">The cancer cells will be analyzed to learn about the genetic mutations they contain. </li> <li class="seamTextUnorderedListItem">In a lab, your white blood cells will be modified in ways that will help them go after your tumor cells. </li> <li class="seamTextUnorderedListItem">They will then be infused into your body. This will take place in the hospital where the research study is taking place. </li> <li class="seamTextUnorderedListItem">When you receive the infused T cells, you will also be given Aldesleukin, an immune function enhancing drug. </li> <li class="seamTextUnorderedListItem">Your treatment will also include two chemotherapy drugs: cyclophosphamide (Cytoxan), which is used to treat breast cancer, and fludarabine (Fludara), which is approved to treat chronic lymphocytic leukemia (CLL). </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of metastatic cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03412877' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2014/ACTepithelial' target='_blank'>National Cancer Institute Press Release: Immunotherapy</a> </li></ul>
80
NEAREST SITE: 2434 miles
Georgetown Lombardi Comprehensive Cancer Center
Washington,DC
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05256745
Azeliragon to Decrease Cardiotoxicity and Cognitive Decline During Chemotherapy in Women with Stage I-III Breast Cancer
RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer Scientific Title
Purpose
To study the ability of azeliragon to decrease cardiotoxicity (heart damage caused by cancer treatment) and cognitive decline side effects of chemotherapy.
Who is this for?
Women with stage I, stage II, or stage III breast cancer who have not yet received treatment and are planning to receive chemotherapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Azeliragon with AC/T Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), 5.5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 5.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 5.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Azeliragon with CT Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 3-4 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 3-4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Azeliragon with TCHP Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 4 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), 4 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: Azeliragon with Combination of Chemotherapy and Targeted Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 4 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 3-4 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 5.5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), depending on type of cancer</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 months, depending on type of cancer</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon is an experimental drug that may reduce cardiotoxicity and cognitive decline side effects of chemotherapy. It is also being studied for treating Alzheimer's and glioblastoma, a type of brain cancer.</li> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity. </li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), paclitaxel (Taxol®), docetaxel (Taxotere®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are anti-HER2 targeted therapies routinely used to treat HER2 positive 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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05256745' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/16858-chemotherapy--the-heart-cardiotoxicity#:~:text=Cardiotoxicity%20refers%20to%20any%20heart,radiation%20therapy%20to%20the%20chest.' target='_blank'>Cleveland Clinic: Cardiotoxicity Cancer Treatment and the Heart</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 Brain Cancer and Cancer Treatment-Related Complications</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/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
81
NEAREST SITE: 2453 miles
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,MD
VISITS: At least 8 visits
PHASE: II
NCT ID: NCT06245889
Chemo-Immunotherapy for People Newly Diagnosed with Stage II-III Triple Negative Breast Cancer
A Pilot Study of Neoadjuvant Response-Adapted Chemotherapy With Pembrolizumab in Patients With Stage 2 and 3 Triple Negative Breast Cancer to Determine Early PET and Biomarker Dynamics (NeoADAPT) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of paclitaxel (Taxol®) and carboplatin (Paraplatin®) chemotherapy with pembrolizumab (Keytruda®) PD-1 inhibitor, as well as further treatment based on treatment response.
Who is this for?
People with stage II or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have not yet received treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">PET scan, 2 times</li> <li class="seamTextUnorderedListItem">ctDNA tests, 4 times</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 4 cycles</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 cycles</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), 4 cycles</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery (if complete response) or additional chemotherapy (if residual disease)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receiving chemotherapy with immunotherapy is called chemo-immunotherapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are chemotherapy drugs.</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">Residual disease refers to cancer cells present after chemotherapy.</li> <li class="seamTextUnorderedListItem">Complete response to no cancer cells present after chemotherapy.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</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">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer to look for signs of disease, including cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06245889' target='_blank'>ClinicalTrials.gov</a> </li></ul>
82
NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge,NJ
VISITS: 1 visit every 1-2 weeks
PHASE: II
NCT ID: NCT05570253
Evexomostat and Chemotherapy for People with Advanced Triple Negative Breast Cancer and High Blood Sugar or High BMI
Phase 2 Randomized Control Trial of Evexomostat (SDX-7320) in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of eribulin (Halaven®) chemotherapy with or without evexomostat (SDX-7320), an experimental polymer drug conjugate.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who have high blood sugar or a BMI of at least 30 kg/m^2. You must have received chemotherapy and must not have received more than 2 lines of therapy for advanced or metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320), by injection, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo for evexomostat (SDX-7320)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05570253' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aretha1.com/' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>
83
NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05716893
Exercise During Chemotherapy for People with Stage I-III Breast Cancer
Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Chemotherapy for Primary Breast Cance Scientific Title
Purpose
To study how 2 types of walking aerobic training affect cardiorespiratory fitness.
Who is this for?
Women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to receive chemotherapy. You must not be performing more than 1.5 hours of exercise per week.
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Adaptive Aerobic Training</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Walking aerobic training, 1.5-5 hours per week for 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard (Fixed) Aerobic Training</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Walking aerobic training, 1.5 hours per week for 1 year</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cardiorespiratory fitness (CRF) is the ability of your heart and lungs to deliver oxygen to your body’s muscles and organs during physical activity.</li> <li class="seamTextUnorderedListItem">Aerobic exercise refers to cardiovascular exercise, which includes activities such as walking, running, biking, and swimming.</li> <li class="seamTextUnorderedListItem">Adaptive aerobic training consists of changing the amount of exercise depending on your response.</li> <li class="seamTextUnorderedListItem">Standard (fixed) aerobic training consists of a fixed, constant amount of exercise.</li> <li class="seamTextUnorderedListItem">Some of your walking will be supervised remotely (online).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05716893' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/exercise-during-after-cancer-treatment-level-1' target='_blank'>Memorial Sloan Kettering Cancer Center: Exercise During and After Cancer Treatment</a> </li></ul>
84
NEAREST SITE: 2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick,NJ
VISITS: 10 visits within 5 years
PHASE: II
NCT ID: NCT05949021
Chemotherapy After Surgery for Women with Stage I-II Triple Negative Breast Cancer
OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of liposomal doxorubicin (Adriamycin®) and carboplatin (Paraplatin®) chemotherapy after surgery (adjuvant).
Who is this for?
Women with stage I or stage II triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have received surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Liposomal doxorubicin (Adriamycin®), monthly for 4 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), monthly for 4 months</li> <li class="seamTextUnorderedListItem">ctDNA tests, 7 visits within 5 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Liposomal doxorubicin (Adriamycin®) and carboplatin (Paraplatin®) are chemotherapy drugs commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin (Adriamycin®) is doxorubicin (Adriamycin®) in tiny spheres that keep the drug in the bloodstream longer so that more drug reaches the cancer cells.</li> <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">This trial is also studying the use of ctDNA to detect treatment response and disease progression.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH negative.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05949021' 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.cancerresearchuk.org/about-cancer/treatment/drugs/liposomal-doxorubicin' target='_blank'>Cancer Research UK: Liposomal Doxorubicin (Adriamycin®)</a> </li></ul>
85
NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center
New York,NY
VISITS: At least 6 visits, may require hospitalization
PHASE: I
NCT ID: NCT04150042
Stem Cells with Chemotherapy for Metastatic HER2- Breast Cancer with an Inherited BRCA1/2 or PALB2 Mutation
SHARON: Study of Metastatic Cancers in Patients With an Inherited Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of stem cells with melphalan chemotherapy.
Who is this for?
People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with an inherited (germline) BRCA1, BRCA2, or PALB2 mutation.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to collect stem cells</li> </ul> <p class="seamTextPara"> followed by 2 rounds of: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Melphalan, by IV</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), by IV</li> <li class="seamTextUnorderedListItem">Vitamin B12b, by IV</li> <li class="seamTextUnorderedListItem">Vitamin C, by IV</li> <li class="seamTextUnorderedListItem">Ethanol, by IV</li> </ul> <p class="seamTextPara"> followed 2 days later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stem cells, by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your stem cells will be collected from your body and modified in a lab so they can identify and attack cancer cells. These modified stem cells will then be infused back into your body.</li> <li class="seamTextUnorderedListItem">Apheresis is a procedure to collect your stem cells. </li> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor is a drug that will help prepare your body and stem cells for apheresis.</li> <li class="seamTextUnorderedListItem">Melphalan is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), vitamin B12b, vitamin C, and ethanol will be given to improve the effectiveness of the stem cell infusion.</li> <li class="seamTextUnorderedListItem">You will receive two rounds of melphalan (Alkeran®) chemotherapy and stem cell infusion approximately 6 weeks apart.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PALB2</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04150042' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sharontrial.com/' target='_blank'>General Oncology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.facingourrisk.org/research-clinical-trials/study/117/a-study-of-melphalan-bcnu-vitamin-b12b-vitamin-c-and-stem-cell-infusion-in-people-with-advanced-pancreatic-cancer-and-brca-mutations' target='_blank'>Facing Our Risk of Cancer Empowered: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/autologous-stem-cell-transplant/pyc-20384859' target='_blank'>Mayo Clinic: Autologous Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/stem-cell-transplant/process.html' target='_blank'>American Cancer Society: Getting a Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/melphalan-intravenous-route/side-effects/drg-20071590?p=1#:~:text=Melphalan%20injection%20is%20used%20to,alkylating%20agents%20(cancer%20medicines).' target='_blank'>Mayo Clinic: Melphalan</a> </li></ul>
86
NEAREST SITE: 2569 miles
Mount Sinai Health System
New York,NY
VISITS: 1 visit every week for 3 months
PHASE: I
NCT ID: NCT06637306
Dupilumab, Pembrolizumab, and Chemotherapy Before Surgery for Stage II-III Triple Negative Breast Cancer
Pilot Trial of the IL-4 Receptor Antagonist Dupilumab Plus Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of dupilumab (Dupixent®), an experimental immunotherapy, with pembrolizumab (Keytruda®) immunotherapy and paclitaxel (Taxol®) and carboplatin (Paraplatin®) chemotherapies before surgery (neoadjuvant).
Who is this for?
People with stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dupilumab (Dupixent®), by injection, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> <p class="seamTextPara"> followed 1 week later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, 1 time</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dupilumab (Dupixent®) is an immunotherapy drug approved for people with eczema, asthma, and other conditions. Its use in this trial is considered experimental.</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">Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are chemotherapy drugs.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06637306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/drugs/20590-dupilumab-injection' target='_blank'>Cleveland Clinic: Dupilumab (Dupixent®)</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/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/carboplatin' target='_blank'>Cancer Research UK: Carboplatin (Paraplatin®)</a> </li></ul>
87
NEAREST SITE: 2587 miles
Miami Cancer Institute at Baptist Health, Inc.
Miami,FL
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05553522
Targeted Therapy, Chemotherapy, and Stereotactic Radiosurgery for Metastatic HER2+ Breast Cancer with Brain Metastases
Phase 1 Trial of Tucatinib, Trastuzumab, and Capecitabine With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From HER-2 Positive Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of stereotactic radiosurgery (SRS) with tucatinib (Tukysa®) tyrosine kinase inhibitor, capecitabine (Xeloda®) chemotherapy, and trastuzumab (Herceptin®) anti-HER2 targeted therapy.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis). Your brain metastases must be newly diagnosed.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS)</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 2 weeks</li> </ul> <p class="seamTextPara"> followed 2 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <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> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat 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">Stereotactic radiosurgery (SRS, stereotactic radiation) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">The combined use of SRS with the three drugs is considered investigational.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05553522' 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 (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</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.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li></ul>
88
NEAREST SITE: 2619 miles
Dartmouth Hitchcock Medical Center
Lebanon,NH
VISITS: At least 1 visit every 3-6 weeks
PHASE: I-II
NCT ID: NCT06134375
Tetrathiomolybdate with Chemotherapy and Immunotherapy After Surgery for Stage I-III Triple Negative Breast Cancer
Novel Targeting of the Microenvironment to Decrease Metastatic Recurrence of High-Risk TNBC: a Randomized Phase II Study of Tetrathiomolybdate (TM) Plus Capecitabine in Patients with Breast Cancer At High Risk of Recurrence Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of tetrathiomolybdate, an experimental copper depletion (removal) drug, with standard of care capecitabine (Xeloda®) chemotherapy and pembrolizumab (Keytruda®) PD-1 inhibitor.
Who is this for?
People with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have received chemotherapy before surgery (neoadjuvant) and surgery within the last 3 months. You must also either have node positive disease after treatment or have a Residual Cancer Burden (RCB) score of 2 or 3.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tetrathiomolybdate, by mouth, daily for 3 years</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> </ul> <p class="seamTextPara"> with or without: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> </ul> <p class="seamTextPara"> with or without: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 6 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tetrathiomolybdate is a drug that removes copper from the body (copper depletion) and is used to treat other diseases and some advanced cancers.</li> <li class="seamTextUnorderedListItem">Removing copper from the body may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Adding tetrathiomolybdate to standard of care treatment may make the treatment more effective.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</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">Node positive means that cancer has spread to the lymph nodes.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06134375' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/copper-depletion-combats-metastatic-recurrence-in-high-risk-tnbc' target='_blank'>OncLive: Tetrathiomolybdate for Triple Negative Breast Cancer</a> </li></ul>
89
NEAREST SITE: 2693 miles
Brigham and Women's Hospital
Boston,MA
VISITS: 1 visit every 1-3 weeks
PHASE: II
NCT ID: NCT04986579
Scalp Cooling to Prevent Hair Loss During Chemotherapy for People With Metastatic Breast Cancer
Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer Scientific Title
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.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Chemotherapy with Scalp Cooling</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Chemotherapy without Scalp Cooling</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or trastuzumab deruxtecan (Enhertu®), by IV, every 1-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<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>
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<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>
90
NEAREST SITE: 2693 miles
Dana-Farber Cancer Institute
Boston,MA
VISITS: 1 visit every 1-3 weeks for 1.5 years
PHASE: II
NCT ID: NCT06439693
Multiple Anti-HER2 Targeted Therapies for de Novo Metastatic HER2+ Breast Cancer
A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study Scientific Title
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).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <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> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks for 4-5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <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> <p class="seamTextPara"> followed by: </p> <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>
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<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>
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<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>
