Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

Official Title

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

Keywords

Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer, Breast Neoplasms, Paclitaxel, Albumin-Bound Paclitaxel, Capecitabine, Sacituzumab govitecan, Sacituzumab Govitecan-hziy, Nab-paclitaxel, Sacituzumab Govitecan-hziy (SG)

Eligibility

Locations

  • UCSF (UCSF) Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94143 United States
  • Stanford Cancer Institute
    Palo Alto California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT05840211
Phase
Phase 3 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 654 study participants
Last Updated