A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Trial Details

NCT ID
NCT06790693
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Inavolisib
  • Placebo
  • CDK4/6i
  • Letrozole
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Burbank, California, United States|34.18084,-118.30897
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Alamitos, California, United States|33.80307,-118.07256
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Women or men with histologically or cytologically confirmed carcinoma of the breast
  • Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologi…
  • Documented HER2-negative tumor according to ASCO/CAP guidelines
  • De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy with…

For full eligibility, visit ClinicalTrials.gov.

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