In short
Clinical trials for Immunostimulants are being studied in patients with cancer to see how well they work and how safe they are. The trial data here focuses on people with hormone receptor-positive, HER2-negative metastatic breast cancer who have already had endocrine therapy. The main goal is to compare treatment effects, especially progression-free survival.
Key points
- Clinical trial data for Immunostimulants focuses on cancer research, especially locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. The study is a Phase 3 interventional trial with 867 planned participants. It looks at patients who have already received endocrine-based treatment. The main endpoint is progression-free survival, which measures how long the cancer does not get worse. The trial compares treatment effect against the physician’s choice of other care.
Trial overview
This clinical trial is an interventional study, which means participants receive a treatment so researchers can measure the effect. It is studying patients with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer who have already received an endocrine-based regimen.
The study is authorised and is planned as a Phase 3 trial with 867 participants. The brief goal is to compare the effect of SG relative to the TPC on progression-free survival.
Who can join
The target population is people with locally advanced or metastatic breast cancer. The cancer must be hormone receptor-positive (HR-positive) and HER2-negative.
Another key requirement is that patients must have already received an endocrine-based regimen, which is a treatment plan based on hormone therapy.
What is being compared
The trial compares SG with treatment of physician’s choice (TPC). TPC means the doctor chooses from the treatment options allowed in the study.
The listed treatment options include Trodelvy, Xeloda, Paclitaxel, and Abraxane, along with other study drug entries shown in the source data.
Trial phase and size
This is a Phase 3 trial. Phase 3 trials are usually late-stage studies that compare treatments in larger groups of patients.
The planned enrollment is 867 people. A larger study size can help researchers compare treatment results more clearly.
Main endpoint
The main endpoint is progression-free survival (PFS). 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.
Progression is checked by blinded independent central review (BICR) using RECIST v1.1, which is a standard system for measuring tumor changes on scans.