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

January, 2020

Scientific title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

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

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Double, Subject masked: Yes, Investigator masked: Yes,

Conditions

Breast Cancer

Other study ID numbers

WO41554; 2019-002455-42

Choose trial site (301)