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

NCT05382299 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 623

Last updated 2026-04-06

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) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

Conditions

Interventions

DRUG

Sacituzumab Govitecan-hziy

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
2022-07-20
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • 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 NCT05382299 on ClinicalTrials.gov