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Recruiting Phase 3 Interventional

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

ClinicalTrials.gov ID: NCT05646862

Public ClinicalTrials.gov record NCT05646862. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 16, 2026, 1:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.

Study identification

NCT ID
NCT05646862
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
420 participants

Conditions and interventions

Conditions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 7, 2023 (Actual)
Primary completion
Nov 13, 2026 (Estimated)
Completion
Mar 30, 2029 (Estimated)
Last update posted
Sep 28, 2026

2023 – 2029

United States locations

U.S. sites
39
U.S. states
16
U.S. cities
35
Facility City State ZIP Site status
Marin Cancer Care Inc Greenbrae California 94904 Withdrawn
Cancer Blood and Specialty Clinic Los Alamitos California 90720 Active, not recruiting
Los Angeles Cancer Network Los Angeles California 90017-4803 Active, not recruiting
University of California, Irvine Medical Center Orange California 92868 Withdrawn
UC Davis Comprehensive Cancer Center Sacramento California 95817 Active, not recruiting
Rocky Mountain Cancer Centers Denver Colorado 80220 Completed
Banner MD Anderson Cancer Center Greeley Colorado 85234 Withdrawn
Eastern CT Hematology and Oncology Associates Norwich Connecticut 06360-2740 Withdrawn
Cancer Care Centers of Brevard Palm Bay Florida 32901 Withdrawn
Cleveland Clinic Florida Weston Florida 33331 Active, not recruiting
Grady Health System Atlanta Georgia 30303 Active, not recruiting
Midtown West Medical Atlanta Georgia 30318 Active, not recruiting
Emory University Hospital Atlanta Georgia 30322 Recruiting
Winship Cancer Institute at Emory Saint Joseph's Hospital Atlanta Georgia 30342 Active, not recruiting
University of Louisville Hospital Louisville Kentucky 40202 Withdrawn
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
Karmanos Cancer Institute. Detroit Michigan 48201 Withdrawn
Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan 49503 Completed
Minnesota Oncology Hematology Saint Paul Minnesota 55102 Active, not recruiting
MD Anderson Cancer Center at Cooper Camden New Jersey 08103 Withdrawn
Novant Health Presbyterain Medical Center Charlotte North Carolina 28204 Withdrawn
Novant Health Forsyth Medical Center Winston-Salem North Carolina 27103 Withdrawn
Gabrail Cancer Center Canton Ohio 44718 Withdrawn
Asante Rogue Regional Medical Center Medford Oregon 97504-8332 Completed
Bryn Mawr Hospital Bryn Mawr Pennsylvania 19010-3121 Withdrawn
St. Lukes Hospital and Health Network Easton Pennsylvania 18045 Withdrawn
Paoli Memorial Hospital Paoli Pennsylvania 19301 Withdrawn
Abramson Cancer Center Chester County Hospital West Chester Pennsylvania 19380 Withdrawn
Lankenau Medical Center, Cancer Center Wynnewood Pennsylvania 19096 Withdrawn
Main Line Health System Wynnewood Pennsylvania 19096 Withdrawn
WellSpan Oncology Research York Pennsylvania 17403 Withdrawn
Texas Oncology West Amarillo Texas 79106 Withdrawn
Texas Oncology - Dallas Presbyterian Hospital Dallas Texas 75231 Active, not recruiting
Texas Tech University Health Sciences Center El Paso Texas 79905 Withdrawn
Texas Oncology (Flower Mound) - USOR Flower Mound Texas 75028 Withdrawn
The Center for Cancer and Blood Disorders - Fort Worth Fort Worth Texas 76104 Withdrawn
Lumi Research Kingwood Texas 77339 Withdrawn
Texas Oncology McKinney McKinney Texas 75071 Withdrawn
Kadlec Clinic Hematology and Oncology Kennewick Washington 99336-7774 Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 171 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05646862, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2026 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05646862 live on ClinicalTrials.gov.

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