In short
Clinical trials are investigating 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE in people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This article explains what the trial is trying to measure, who may join, and the phase and main outcome being studied.
Key points
- Clinical trials are studying 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE in people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The trial is a Phase 3, interventional study with about 400 participants planned. It focuses on people whose disease has progressed after a prior treatment. The main outcome is progression-free survival, which measures how long the cancer stays from getting worse. The study compares 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE plus fulvestrant with other treatment options.
Trial overview
This study is testing 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE in people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The trial is designed to see whether the study treatment works better than the comparison treatment after a previous line of therapy has stopped working.
Who the trial is for
The target population is people with advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative. The study also focuses on patients whose disease has progressed after prior treatment, which means the cancer has gotten worse despite earlier therapy.
What the study compares
The brief summary says the study aims to show the superiority of 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE plus fulvestrant over ICT, which is the comparator treatment arm in this trial. The listed treatments include fulvestrant, everolimus, and exemestane, showing that the study includes treatment combinations used in different arms.
Trial phase and size
This is a Phase 3 trial, which usually means a larger study that compares treatments in many participants to learn how well they work. The planned enrollment is 400 people, so the study is designed to include a fairly large patient group. The study status is Authorised.
Main endpoint
The main endpoint is progression-free survival (PFS), which is the time from randomization until the cancer first gets worse or the person dies from any cause, whichever happens first. The study measures this using blinded independent central review (BICR) and RECIST v1.1, which are standard ways to assess tumor changes in a fair and consistent way.
What the results will show
If the trial shows better PFS for 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE plus fulvestrant, it would suggest that this treatment combination may help delay cancer growth longer than the comparison treatment. Because this is a Phase 3 study, the results are meant to give stronger evidence about how the treatment performs in the target patient group.