Table of Contents
Trial overview
This clinical trial is an interventional study, which means participants receive a treatment so researchers can measure the effect.[1] It is studying patients with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer who have already received an endocrine-based regimen.[1]
The study is authorised and is planned as a Phase 3 trial with 867 participants.[1] The brief goal is to compare the effect of SG relative to the TPC on progression-free survival.[1]
Who can join
The target population is people with locally advanced or metastatic breast cancer.[1] The cancer must be hormone receptor-positive (HR-positive) and HER2-negative.[1]
Another key requirement is that patients must have already received an endocrine-based regimen, which is a treatment plan based on hormone therapy.[1]
What is being compared
The trial compares SG with treatment of physician’s choice (TPC).[1] TPC means the doctor chooses from the treatment options allowed in the study.[1]
The listed treatment options include Trodelvy, Xeloda, Paclitaxel, and Abraxane, along with other study drug entries shown in the source data.[1]
Trial phase and size
This is a Phase 3 trial.[1] Phase 3 trials are usually late-stage studies that compare treatments in larger groups of patients.[1]
The planned enrollment is 867 people.[1] A larger study size can help researchers compare treatment results more clearly.[1]
Main endpoint
The main endpoint is progression-free survival (PFS).[1] This means the time from randomization until the cancer gets worse, called objective progressive disease (PD), or until death from any cause, whichever happens first.[1]
Progression is checked by blinded independent central review (BICR) using RECIST v1.1, which is a standard system for measuring tumor changes on scans.[1]
