A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Trial Details

NCT ID
NCT05894239
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Inavolisib
  • Phesgo
  • Placebo
  • Taxane-based Chemotherapy
  • Optional Endocrine Therapy of Investigator's Choice
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Burbank, California, United States|34.18084,-118.30897
  • Corona, California, United States|33.87529,-117.56644
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311

Key Eligibility Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to c…
  • Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
  • Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor …

For full eligibility, visit ClinicalTrials.gov.

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