Clin2
NCT05646862Possibly a fitRecruiting

Comparing two treatments for advanced breast cancer with a PIK3CA mutation

Breast Cancer

Treatments studied

InavolisibFulvestrantAlpelisibBupropionOmeprazoleMidazolam

Part of Cancer, Skin clinical trials.

This trial tests whether a new drug combo (inavolisib plus fulvestrant) works better than an existing one (alpelisib plus fulvestrant) for people with a specific type of advanced breast cancer that has a PIK3CA mutation. It aims to find a treatment that may help control the cancer longer.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
420 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have advanced or metastatic breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-).
  • Your tumor has a specific change called a PIK3CA mutation.
  • Your cancer has grown during or after treatment with a CDK4/6 inhibitor combined with hormone therapy (endocrine therapy).
  • You have not had more than 2 prior treatments for advanced cancer, and you may have had one chemotherapy in the advanced setting.
  • Your doctor recommends hormone-based therapy, not chemotherapy, for your current situation.
  • You are generally well enough to be able to look after yourself (ECOG performance status 0, 1, or 2).

View the official record on ClinicalTrials.gov

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