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
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
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.
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:
Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment.
Adequate organ function.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
GileadClinicalTrials@gilead.com1-833-445-3230 (GILEAD-0)
Fountain Valley, California 92708, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20010, United States
Newnan, Georgia 30265, United States
Skokie, Illinois 60076, United States
Baltimore, Maryland 21231, United States
Methuen, Massachusetts 01844, United States
Milford, Massachusetts 01757, United States
South Weymouth, Massachusetts 02190, United States
Grand Rapids, Michigan 49503, United States
Southfield, Michigan 48075, United States
Minneapolis, Minnesota 55455, United States
Hastings, Nebraska 68901, United States
Omaha, Nebraska 68124, United States
East Syracuse, New York 13057, United States
Charlotte, North Carolina 28204, United States
Greensboro, North Carolina 27403, United States
Greenville, North Carolina 27834, United States
Bend, Oregon 97701, United States
Portland, Oregon 97213, United States
Philadelphia, Pennsylvania 19104, United States
Wytheville, Virginia 24382, United States
Green Bay, Wisconsin 54303, United States
Campbelltown, New South Wales 2560, Australia
Brasília, 71681-603, Brazil
Curitiba, 80510-130, Brazil
Itajaí, 88300-000, Brazil
Porto Alegre, 90020-090, Brazil
São Paulo, 01509-010, Brazil
Teresina, 60449-200, Brazil
Loire Atlantique, 44 805, France
Berlin, 13597, Germany
Koblenz, 56068, Germany
Traunstrein, 83278, Germany
Wilton, T12 DC4A, Ireland
Meldola, 47014, Italy
Chungcheongnam-do, 31151, South Korea
Seodaemun-gu, 3722, South Korea
Edgbaston, B152TH, United Kingdom
Liverpool, L7 8YA, United Kingdom