Study on Sacituzumab Govitecan and Talazoparib for Patients with Metastatic Breast Cancer
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT04039230
This clinical trial is exploring a new treatment combination of Sacituzumab Govitecan and Talazoparib for patients with metastatic triple-negative breast cancer. The study aims to determine if this combination is safe and effective in stopping cancer growth and spread.
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Program Overview
This study is testing a new treatment for metastatic triple-negative breast cancer using two drugs: Sacituzumab Govitecan and Talazoparib. Sacituzumab Govitecan is a type of drug that combines an antibody with an anticancer drug to target cancer cells directly. Talazoparib is a drug that stops cancer cells from repairing their DNA, making it harder for them to survive. The goal is to see if using these drugs together can help control the cancer. This is a Phase I/II trial, meaning it is in the early stages of testing to find the safest dose and to see how well the treatment works.
Description
This clinical trial is in its early stages (Phase I/II) and is testing a new combination of drugs for treating metastatic triple-negative breast cancer. Sacituzumab Govitecan is an investigational drug, meaning it is still being studied and not yet approved by the FDA for any disease. It works by using an antibody to deliver an anticancer drug directly to the tumor. Talazoparib is a PARP inhibitor, a type of drug that prevents cancer cells from repairing their DNA, which can help stop them from growing and spreading. The study aims to find out if this combination is safe and effective in treating this type of breast cancer. Participants will receive these drugs and be monitored for safety and how well the treatment works.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with stage IV (metastatic) breast cancer.
- Cancer must be triple-negative, meaning it does not have estrogen, progesterone, or HER2 receptors.
- Both premenopausal and postmenopausal women can participate.
- Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have measurable disease according to specific medical criteria.
- Must understand and agree to sign a consent form to participate.
- Must be at least two weeks past any previous cancer treatments or major surgery and have recovered from any side effects.
- Must have adequate bone marrow and organ function based on specific blood test results.
- Must have controlled blood sugar levels and meet specific criteria for liver and kidney function.
Exclusion Criteria
- Have had recent cancer treatments or not fully recovered from previous treatment side effects.
- Have received certain prior cancer treatments like irinotecan or similar drugs.
- Have worsening cancer in the brain or central nervous system unless stable for at least one month.
- Are taking certain medications that affect how the study drugs work.
- Have uncontrolled illnesses or conditions that could interfere with the study.
- Have significant heart disease or abnormal heart rhythms.
- Are HIV-positive and on antiretroviral therapy.
- Are pregnant or breastfeeding.
- Are not using effective birth control if of childbearing potential or a fertile male.
- Have a history of severe allergic reactions to similar drugs.
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