Sacituzumab Govitecan + Pembrolizumab for Triple Negative Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received any prior chemotherapy or biologic therapy for metastatic breast cancer within 28 days before starting the study treatment. You can continue or start bisphosphonates or RANK ligand inhibitors if needed.
What data supports the effectiveness of the drug Sacituzumab Govitecan for treating triple-negative breast cancer?
Sacituzumab Govitecan has shown effectiveness in treating metastatic triple-negative breast cancer, with a study reporting a 33.3% response rate and a median response duration of 7.7 months. It is well tolerated and has been approved by the FDA for patients who have tried at least two other treatments.12345
What is known about the safety of Sacituzumab Govitecan and Pembrolizumab for human use?
Sacituzumab Govitecan has been studied in patients with advanced solid tumors, showing common side effects like nausea, fatigue, and diarrhea, but is generally well tolerated. Pembrolizumab, also known as KEYTRUDA, is widely used in various cancers and has a known safety profile, but specific safety data for the combination with Sacituzumab Govitecan in triple-negative breast cancer is not detailed in the provided research.12346
How is the drug Sacituzumab Govitecan + Pembrolizumab unique for treating triple-negative breast cancer?
This drug combination is unique because Sacituzumab Govitecan is an antibody-drug conjugate that targets a specific protein (Trop-2) on cancer cells and delivers a potent chemotherapy agent (SN-38) directly to the tumor, while Pembrolizumab is an immunotherapy that helps the immune system attack cancer cells. This combination offers a novel approach by combining targeted therapy with immunotherapy for treating triple-negative breast cancer.12367
What is the purpose of this trial?
This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative.The names of the study interventions involved in this study are:* Sacituzumab govitecan (Trodelvy™;IMMU-132)* Pembrolizumab (Keytruda®; MK-3475)
Research Team
Ana C. Garrido-Castro
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults with PD-L1-negative metastatic triple-negative breast cancer (TNBC). Participants must have not received treatment for metastasis, be in good physical condition, and have normal organ/marrow function. They should agree to a research biopsy if possible. Pregnant women or those breastfeeding are excluded, as well as anyone with certain medical conditions or recent treatments that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Sacituzumab Govitecan with or without Pembrolizumab in 21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Second Course Phase
Participants who achieve CR after at least 24 weeks of treatment may receive additional therapy if they progress
Treatment Details
Interventions
- Pembrolizumab
- Sacituzumab Govitecan
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
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Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University