OncRef

Clinical Trial: NCT02574455

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Gilead Sciences
Information Provided By:Gilead Sciences
Last Update Posted:2022-06-15

Study Overview

Brief Summary

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

Official Title

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Sacituzumab govitecan
  • Drug: Eribulin
  • Drug: Capecitabine
  • Drug: Gemcitabine
  • Drug: Vinorelbine

Other Study ID Numbers

  • IMMU-132-05
  • 2017-003019-21
  • 2017

Start Date (Actual)

2017-11-07

Primary Completion Date (Actual)

2020-03-30

Study Completion Date (Actual)

2020-12-08

Enrollment (Actual)

529

Study Type

Interventional

Phase

Phase 3