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 monotherapy. After the monotherapy cohort completes enrollment, the combination therapy cohort (SG with pembrolizumab) for patients with localized BC will open. Future planned arms include SG with/without pembrolizumab for patients with Hormone Receptor positive (HR+) breast cancer and inflammatory breast cancer (IBC). The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Eligible participants will receive Sacituzumab govitecan for up to 12 weeks. * This can be followed by standard chemotherapy at the discretion of the treating physician. * It is expected that about 50 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved Sacituzumab govitecan as a treatment for patients with metastatic TNBC. Sacituzumab govitecan (SG) is an antibody-drug conjugate which means it's made up of an antibody attached to an anticancer drug. An antibody is a protein normally made the immune system. Sacituzumab govitecan is believed to work by binding the antibody portion of the drug in the tumor(s) while the anticancer drug portion works to prevent cancer cells from growing/spreading. After the SG monotherapy cohort completes enrollment, the combination therapy cohort (SG with immunotherapy) will open.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
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)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
Pathological complete response(pCR) rate with sacituzumab govitecan
pCR is defined as no residual invasive carcinoma in the breast and in the lymph node. The two-sided 95% CIs for pCR rate will be calculated.
Time frame: 12 Weeks
Disease-Free Survival
Kaplan-Meier methods and descriptive statistics
Time frame: Time from the first dose of study treatment to disease recurrence/progression by RECIST v1.1 or death due to any cause, up to 36 months
Overall Survival
Kaplan-Meier methods and descriptive statistics
Time frame: defined as the time from the first dose of study treatment to the date of death or last contact up to 36 months
Change in Breast Conserving Surgery Rate (BCS) rate
RCB calculator: http:// RCB calculator: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Time frame: 12 Weeks
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
CTCAE v5.0
Time frame: Baseline to 12 weeks
Assessment of Quality of life (QOL)
EORTC questionnaire
Time frame: Baseline up to 12 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Masking
NONE
Enrollment
260
Massachusetts General Hospital - North Shore Cancer Center
Danvers, Massachusetts, United States
RECRUITINGMassachusetts General Hospital at Newton-Wellesley Hospital
Newton, Massachusetts, United States
RECRUITING