A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
- Trial number:
- NCT04191499
- Trial phase:
- 2, 3
- Study type:
- Targeted therapy, Biomarker, Hormonal therapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Confirmed diagnosis of HR+/HER2- breast cancerMetastatic or locally advanced disease not amenable to curative therapy Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test) Consent to provide fresh or archival tumor tissue specimen Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible Eastern Cooperative Oncology Group Performance Status of 0 or 1 Life expectancy of > 6 months Adequate hematologic and organ function within 14 days prior to initiation of study treatment