Observing the Effects of Two Treatments for Metastatic Triple-Negative Breast Cancer
NCT04468061 · RecruitingThis study is looking at the safety and effectiveness of two medicines for patients with metastatic triple-negative breast cancer (TNBC) that does not express PD-L1. The medicines being tested are Sacituzumab Govitecan and Pembrolizumab. The goal is to see if using these medicines together or separately can help delay the cancer from getting worse.
Locations and contact
This trial is running at 15 locations in the United States. All of them are currently recruiting.
United States15 locations · 15 recruiting
- Dana Farber Cancer InstituteBoston, MassachusettsRecruiting
- DF/BWCC in Clinical Affiliation with South Shore HospitalSouth Weymouth, MassachusettsRecruiting
- DFCI @ FoxboroughFoxborough, MassachusettsRecruiting
- DFCI @ Milford Regional HospitalMilford, MassachusettsRecruiting
- Eastern Maine Medical CenterBrewer, MaineRecruiting
- Medical University of South CarolinaCharleston, South CarolinaRecruiting
- Miami Cancer Institute at Baptist HealthPlantation, FloridaRecruiting
- Miami Cancer Institute at Baptist Health (Kendall)Miami, FloridaRecruiting
- Ohio State University Medical CenterColumbus, OhioRecruiting
- Sarah Cannon Research InstituteChattanooga, TennesseeRecruiting
- Stamford HospitalStamford, ConnecticutRecruiting
- The Christ Hospital Cancer CenterCincinnati, OhioRecruiting
- The University of North Carolina at Chapel HillChapel Hill, North CarolinaRecruiting
- University of Chicago Medical CenterChicago, IllinoisRecruiting
- University of Pennsylvania-Abramson Cancer CenterPhiladelphia, PennsylvaniaRecruiting
Who can join
This trial is open to adults, age 18 and older, who have been diagnosed with metastatic breast cancer that is triple-negative and PD-L1-negative. Participants must not have received any prior treatment for metastatic breast cancer. The trial team will confirm who is eligible before joining.
What happens during the trial
Participants will be placed into one of two groups by chance. Group A will receive Sacituzumab Govitecan and Pembrolizumab, while Group B will receive Sacituzumab Govitecan alone. Treatment will last as long as it helps the participant. Everyone will receive the treatment during a 21-day cycle, with specific days for each medicine.
The trial team
The trial is led by the Dana-Farber Cancer Institute, with Dr. Ana C Garrido-Castro as the principal investigator. Collaborating organizations include Gilead Sciences and Merck Sharp & Dohme LLC.
Important dates
The trial started on July 20, 2020, and is expected to finish in April 2029. It is currently enrolling new participants.
Additional information
The trial's ID number is NCT04468061. It is a Phase 2 study, which means it is looking at how well the treatments work and how safe they are. The study is FDA-regulated and aims to include about 110 participants.
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