RecruitingPhase 2NCT07368998

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer


Sponsor

Hoffmann-La Roche

Enrollment

80 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — inavolisib (a targeted therapy that blocks a cancer-driving pathway called PI3K) and fulvestrant (a hormone therapy) — for women with hormone receptor-positive, HER2-negative breast cancer that has grown back or spread after prior treatment. **You may be eligible if...** - You have estrogen receptor-positive (ER+), HER2-negative breast cancer that has advanced or spread - Your cancer has a specific mutation in the PIK3CA gene (confirmed by testing) - Your cancer progressed during or after prior CDK4/6 inhibitor therapy combined with hormone therapy - You have had at most one prior treatment regimen for advanced disease - Hormone-based therapy is still the recommended approach for your cancer **You may NOT be eligible if...** - Your tumor does not have the required PIK3CA mutation - You have HER2-positive breast cancer - You have uncontrolled diabetes or other serious conditions that would be worsened by PI3K inhibitors - You are pregnant or breastfeeding - You have received more than one prior treatment line for your advanced/metastatic disease 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.

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Interventions

DRUGInavolisib

Participants will receive Inavolisib as per the schedule given in the protocol.

DRUGFulvestrant

Participants will receive Fulvestrant as per the schedule given in the protocol.


Locations(16)

Los Angeles Cancer Network

Los Angeles, California, United States

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, United States

Cliniques Universitaires St-Luc

Brussels, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

Hospital Universitari Vall d'Hebron;Oncology

Barcelona, Spain

Hospital Universitario San Cecilio

Granada, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Bagcilar Medipol Mega Universitesi Hastanesi

Bağcılar, Istanbul, Turkey (Türkiye)

Adana Baskent University Hospital

Adana, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Medical Park Seyhan Hospital

Seyhan, Turkey (Türkiye)

Blackpool Victoria Hospital

Blackpool, United Kingdom

Princess Alexandra Hospital

Harlow, United Kingdom

Mount Vernon Cancer Centre

Northwood, Middlesex, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07368998


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