Clin2
NCT06757634Possibly a fitRecruiting

A study of gedatolisib for first-line advanced breast cancer

Breast Cancer

Part of Cancer, Skin clinical trials.

This trial tests a new targeted therapy called gedatolisib for people with HR-positive, HER2-negative advanced breast cancer who have not yet received treatment for metastatic disease. It aims to see if adding this drug to standard hormone therapy can help control the cancer longer.

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

Phase
Phase 3
Enrollment
1,180 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have HR-positive, HER2-negative breast cancer that has spread or cannot be removed by surgery and is advanced.
  • You are an adult (male or female) and if you are a woman who can still have children, you must have a negative pregnancy test and use effective birth control during the study and for 2 years after.
  • Your cancer got worse while on or within 12 months of finishing hormone therapy after initial treatment, or you have not had prior systemic therapy for advanced breast cancer.
  • You must have tumor tissue or a blood sample available for testing a gene called PIK3CA.
  • You have at least one tumor that can be measured on scans (measurable disease) and your overall health is good enough for daily activities (ECOG score 0-2).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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