This phase II trial is trying to find out if treatment with a targeted cancer therapy (alpelisib) and a chemotherapy (fulvestrant) increases survival compared to a chemotherapy (capecitabine) alone in men and women with ER+, HER2- breast cancer with a PIKC3A mutation.
This trial is treating patients with ER+, HER2- breast cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
- You have previously been treated (or are currently being treated) on a clinical trial.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Use the hyperlinks, where available to access additional clinical trial information.
A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA
Other Non-Commercial Sponsor
National Health & Medical Research Council (NHMRC)
Eligible patients will be randomised 1:1 to either:
Arm A: alpelisib plus fulvestrant (clinic visits every 28 days) OR Arm B: capecitabine (clinic visits every 21 days).
Recruiting Hospitals Read More