Summary
This clinical trial is testing a new hormone therapy medicine called palazestrant (also known as OP-1250) for people with advanced breast cancer.
The trial is comparing palazestrant with standard hormone treatments, including fulvestrant and aromatase inhibitors (anastrozole, letrozole, or exemestane). The aim is to find out how well palazestrant works compared to standard treatments, how safe it is, and what side effects it causes.
Who is this trial for?
You may be eligible if:
- You have advanced breast cancer that has spread (metastatic) or cannot be cured with surgery (unresectable)
- Your cancer is hormone receptor-positive (ER+) and HER2-negative
- Your cancer has already been treated with hormone therapy and a CDK4/6 inhibitor
- Your cancer has come back or gotten worse after this treatment
What the trial involves
The study is carried out in two stages:
In the first stage, about 120 people will be assigned to receive one of two different doses of palazestrant, or a standard hormone treatment. This helps researchers work out which dose of palazestrant is the most suitable.
In the second stage, around 390 more people will join the trial. They will receive either palazestrant at the chosen dose or a standard hormone treatment.
In both stages, the type of treatment each person receices will be decided randomly (by chance).
Conditions
This trial is treating people with ER+, HER2- locally advanced or metastatic breast cancer whose disease has advanced after receiving at least one hormone therapy in combination with a CDK4/6 inhibitor