To learn if sacituzumab govitecan and pembrolizumab, when given before surgery, can help to control early-stage triple negative breast cancer that has not responded well to other treatments.
Primary Objective: • To determine the efficacy of sacituzumab govitecan and pembrolizumab combination treatment on pathological complete response (pCR)/residual cancer burden (RCB)-1 in the patients with early-stage TNBC who showed a resistance to the combination of immunochemotherapy. Secondary Objectives: * To determine the safety of the proposed combination treatment. * To determine the objective overall response rate (ORR) of the proposed treatment. * To determine the distant-recurrence-free survival (DRFS). * To determine the 3-year event-free survival (EFS) rate. * To determine the 3-year overall survival (OS) rate. Exploratory Objective: • To investigate the response biomarkers in the tumor tissues and peripheral blood.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Given by IV (vein)
Given by IV (vein)
M D Anderson Cancer Center
Houston, Texas, United States
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year.
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