NCT05675579

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan	Given by IV (vein)
DRUG	Pembrolizumab	Given by IV (vein)

Timeline

• Start date: 2023-05-23
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-01-09
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study