OncRef

Clinical Trial: NCT05382286

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Gilead Sciences
Information Provided By:Gilead Sciences
Last Update Posted:2025-09-18

Study Overview

Brief Summary

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Official Title

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

Conditions

Triple Negative Breast Cancer, PD-L1 Positive

Intervention / Treatment

  • Drug: Sacituzumab Govitecan-hziy
  • Drug: Pembrolizumab
  • Drug: Paclitaxel
  • Drug: nab-Paclitaxel
  • Drug: Gemcitabine
  • Drug: Carboplatin

Other Study ID Numbers

  • GS-US-592-6173
  • 2021-005742-14
  • KEYNOTE-D19
  • jRCT2041220123
  • MK-3475-D19
  • 2023-504194-21
  • 2023

Start Date (Actual)

2022-07-25

Primary Completion Date (Estimated)

2027-02

Study Completion Date (Estimated)

2027-02

Enrollment (Actual)

443

Study Type

Interventional

Phase

Phase 3