drugset / Trial / NCT05840211

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

NCT05840211

Phase 3 Active not recruiting 654 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2023-05-08
Primary completion
2028-04
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Comparator Capecitabine Small molecule 1250 mg/m2 Oral
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous

Indications