Spots Global Cancer Trial Database for A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

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Trial Identification

Brief Title: A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

Official Title: A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

Study ID: NCT05675579

Conditions

Breast Cancer

Interventions

Sacituzumab Govitecan

Pembrolizumab

Study Description

Brief Summary: 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.

Detailed Description: 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.