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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

NCT04191499 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2026-03-17

Study results available
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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.

Conditions

Interventions

DRUG

Inavolisib

Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.

DRUG

Placebo

Participants will receive oral placebo on Days 1-28 of each 28-day cycle.

DRUG

Palbociclib

Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

DRUG

Fulvestrant

Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2023-09-29
Completion
2027-11-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Georgia
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Malaysia
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04191499 on ClinicalTrials.gov