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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,514
Administered intravenously
Administered intravenously
Tablets administered orally
Alabama Oncology
Birmingham, Alabama, United States
RECRUITINGClearview Cancer Institute
Huntsville, Alabama, United States
RECRUITINGPalo Verde Hematology Oncology
Glendale, Arizona, United States
RECRUITINGMayo Clinic Hospital
Phoenix, Arizona, United States
Invasive Disease-free Survival (iDFS)
iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.
Time frame: Up to 60 months
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Time frame: Up to 96 months
Distant Disease-free Survival (dDFS)
dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.
Time frame: Up to 60 months
Recurrence-free Survival (RFS)
RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.
Time frame: Up to 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 38 months plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame: First dose date up to 38 months plus 30 days
Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores
TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.
Time frame: Up to 60 months
Gilead Clinical Study Information Center
CONTACT
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Arizona Oncology Associates
Prescott Valley, Arizona, United States
WITHDRAWNAlta Bates Summit Medical Center
Berkeley, California, United States
RECRUITINGCommunity Cancer Institute
Clovis, California, United States
WITHDRAWNPIH Health Whittier Hospital
Downey, California, United States
RECRUITINGCompassionate Cancer Care Medical Group - Inc
Fountain Valley, California, United States
RECRUITINGLos Angeles Cancer Network
Los Angeles, California, United States
RECRUITING...and 278 more locations