A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

Trial Details

NCT ID
NCT07054190
Phase
PHASE2
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Inavolisib
  • Ribociclib
  • Letrozole
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Germantown, Tennessee, United States|35.08676,-89.81009
  • Austin, Texas, United States|30.26715,-97.74306
  • Flower Mound, Texas, United States|33.01457,-97.09696

Key Eligibility Criteria

  • Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classif…
  • Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
  • Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
  • Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines

For full eligibility, visit ClinicalTrials.gov.

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