RecruitingPhase 2NCT07405801

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation

Sponsor

Hoffmann-La Roche

Enrollment

80 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a combination of three medications — inavolisib, ribociclib, and fulvestrant — versus placebo plus ribociclib and fulvestrant in people with advanced hormone receptor-positive (HR+), HER2-negative breast cancer. Researchers want to see if adding inavolisib improves outcomes. **You may be eligible if...** - You have advanced or metastatic breast cancer that is estrogen and/or progesterone receptor-positive and HER2-negative (confirmed by biopsy) - You have not received prior treatment for metastatic breast cancer - Your cancer progressed during or within 12 months of completing adjuvant (post-surgery) hormone-based therapy **You may NOT be eligible if...** - You have a PIK3CA mutation status that excludes you per protocol - You have uncontrolled heart disease or significant abnormal heart rhythm - You have active brain metastases - You have unresolved significant side effects from prior therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGInavolisib

Inavolisib will be administered as per the schedule mentioned in the protocol.

DRUGRibociclib

Ribociclib will be administered as per the schedule mentioned in the protocol.

DRUGFulvestrant

Fulvestrant will be administered as per the schedule mentioned in the protocol.

DRUGPlacebo

Placebo will be administered as per the schedule mentioned in the protocol.

Locations(19)

Avera Cancer Institute - Marshall

Marshall, Minnesota, United States

Avera Cancer Institute - Aberdeen

Aberdeen, South Dakota, United States

Avera Cancer Institute - Mitchell

Mitchell, South Dakota, United States

Avera Cancer Institute - Pierre, SD

Pierre, South Dakota, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

AMG Oncology and Hematology Avera Cancer Institute - Yankton

Yankton, South Dakota, United States

Centro Oncologico Korben

Caba, Argentina

Hospital Santa Rita de Cassia Vitoria

Vitória, Espírito Santo, Brazil

Hospital Brasilia

Brasília, Federal District, Brazil

ICTR Curitiba

Curitiba, Paraná, Brazil

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, Brazil

CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

Chicoutimi, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Soon Chun Hyang University Cheonan Hospital

Dongnam-gu, Cheonan-si, South Korea

Gachon University Gil Medical Center

Namdong-Gu, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07405801

Related Trials

Genomic Services Research Program

NCT025959571 location

Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)

NCT068852031 location

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

NCT052833304 locations

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

NCT06103864316 locations

Sodium-glucose Transporter Type 2 Inhibition in Anthracycline-related Cardiotoxicity

NCT070707652 locations