A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.

Trial Details

NCT ID
NCT05646862
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Inavolisib
  • Fulvestrant
  • Alpelisib
  • Bupropion
  • Omeprazole
  • Midazolam
Locations (sample)
  • Greenbrae, California, United States|37.94854,-122.5247
  • Los Alamitos, California, United States|33.80307,-118.07256
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Sacramento, California, United States|38.58157,-121.4944

Key Eligibility Criteria

  • If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to…
  • Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or ra…
  • Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  • Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test

For full eligibility, visit ClinicalTrials.gov.

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