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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

NCT05382286 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2025-09-18

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Sacituzumab Govitecan-hziy

Administered intravenously

DRUG

Pembrolizumab

Administered intravenously

DRUG

Paclitaxel

Administered intravenously

DRUG

nab-Paclitaxel

Administered intravenously

DRUG

Gemcitabine

Administered intravenously

DRUG

Carboplatin

Administered intravenously

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382286 on ClinicalTrials.gov