Massachusetts General Hospital
This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. This research study involves an experimental study treatment. The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG) The study is a umbrella study multi-arm phase II study of neoadjuvant SG-based therapy in patients with localized BC. The first cohort involves SG m…
Inclusion Criteria: * Female or male patients ≥ 18 years of age. * Histologically confirmed diagnosis of invasive breast cancer, previously untreated. * Pre-and postmenopausal women are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to use effective contraceptive measures that have a failure rate of less than 1% per year from the initiation of treatment through at least 6 months b. after the last dose of study treatment. WOCBP must agree to 1 of the f…
Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)
Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)