To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.

Trial Details

NCT ID
NCT07368998
Phase
PHASE2
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Inavolisib
  • Fulvestrant
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • East Brunswick, New Jersey, United States|40.42788,-74.41598
  • Brussels, Belgium|50.85045,4.34878
  • Hasselt, Belgium|50.93106,5.33781
  • Leuven, Belgium|50.87959,4.70093

Key Eligibility Criteria

  • Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  • Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the loc…
  • Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the s…

For full eligibility, visit ClinicalTrials.gov.

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