A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Gilead Sciences
Summary
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery: * TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)). * Adequate excision and surgical removal of all clinically evident of disease in the breast and/o…
Interventions
- DrugSacituzumab govitecan-hziy (SG)
Administered intravenously
- DrugPembrolizumab
Administered intravenously
- DrugCapecitabine
Tablets administered orally
Locations (339)
- Alabama OncologyBirmingham, Alabama
- Clearview Cancer InstituteHuntsville, Alabama
- Palo Verde Hematology OncologyGlendale, Arizona
- Mayo Clinic HospitalPhoenix, Arizona
- Arizona Oncology AssociatesPrescott Valley, Arizona
- Alta Bates Summit Medical CenterBerkeley, California