Clinical Trial

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

Study acronym: ASCENT-07
Active, Not Recruiting Phase 3
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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).
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2023-04-21; most recent amendment 2025-09-30.
Status change: Recruiting → Active, Not Recruiting 2024-08-27
Trial Details
NCT Number NCT05840211
Lead Sponsor Gilead Sciences
Conditions Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Enrollment 654 participants
Start Date 2023-05-08
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-10-03