Table of contents
- Overview of the trial
- Who the study is for
- What treatments are being compared
- Trial phase and study design
- Main endpoint being measured
- Current status and planned size
Overview of the trial
The available study is an interventional trial, which means researchers are testing a treatment strategy rather than only observing patients.[1] It is studying 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE in people with advanced breast cancer.[1]
The brief summary says the purpose is to show whether PF-07248144 plus fulvestrant works better than the comparison treatment with respect to progression-free survival.[1] Progression-free survival, or PFS, means the time before the cancer gets worse or the person dies from any cause without earlier progression.[1]
Who the study is for
This trial is for people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.[1] In simple words, this is breast cancer that is driven by hormones, does not show HER2 overexpression, and has spread or become advanced.[1]
The study also targets patients whose disease progressed after a prior line of treatment, meaning the cancer grew despite earlier therapy.[1] This tells us the trial is focused on people who still need another treatment option after their previous treatment stopped working well enough.[1]
What treatments are being compared
The trial compares PF-07248144 plus fulvestrant against an investigator-chosen treatment strategy.[1] The intervention list also includes everolimus and exemestane as part of the study treatment options listed in the source data.[1]
Fulvestrant is given by intramuscular injection in the trial data, while PF-07248144, everolimus, and exemestane are listed as oral medicines.[1] The study is designed to compare the outcomes of these treatment approaches rather than to describe how the medicine works in the body.[1]
Trial phase and study design
This is a Phase 3 study.[1] Phase 3 trials usually involve larger numbers of patients and are used to compare how well treatments perform in a real clinical research setting.[1]
The planned enrollment is 400 participants.[1] That number suggests the researchers want enough people in the study to make a meaningful comparison between the treatment groups.[1]
Main endpoint being measured
The main endpoint is progression-free survival, measured from randomization until the first documented disease progression or death from any cause, whichever happens first.[1] Disease progression is assessed by blinded independent central review, or BICR, using RECIST v1.1 criteria.[1]
RECIST v1.1 is a standard way to measure whether cancer is getting smaller, staying stable, or growing on scans.[1] BICR means independent experts review the scan results without knowing which treatment the patient received, which helps reduce bias.[1]
Current status and planned size
The trial status is listed as Authorised.[1] This means the study has been approved to move forward according to the source data.[1]
Only one trial is provided in the source data, so this article focuses on that single Phase 3 study in advanced hormone receptor-positive, HER2-negative breast cancer.[1]
