ACTIVE_NOT_RECRUITING • Phase II, III • Stage III, IV • ER positive • PR positive • HER2 negative • CDK4/6 inhibitor absent • mTOR absent • Somatic PIK3CA present • Medical Oncology • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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

Brief 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.

Description

Study Design

Eligibility Criteria

Arms and Intervention

• Inavolisib

• Placebo

• Palbociclib

• Fulvestrant