OncRef

Clinical Trial: NCT04191499

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-09-11

Study Overview

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.

Official 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

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Inavolisib
  • Drug: Placebo
  • Drug: Palbociclib
  • Drug: Fulvestrant

Other Study ID Numbers

  • WO41554
  • 2019-002455-42
  • 2023-505812-39-00
  • 2023
  • 2019

Start Date (Actual)

2020-01-29

Primary Completion Date (Actual)

2023-09-29

Study Completion Date (Estimated)

2027-11-15

Enrollment (Actual)

325

Study Type

Interventional

Phase

Phase 2, Phase 3