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Advanced Breast Cancer Study: Inavolisib, Ribociclib, and Fulvestrant

This study is looking at a new combination of medicines for people with advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-), and has become resistant to hormone therapy. We are testing if adding inavolisib to ribociclib and fulvestrant works better than a placebo (an inactive substance) combined with ribociclib and fulvestrant. We want to see how many participants have their cancer shrink or disappear (objective response) over about two years. You may be able to join if you are an adult with this type of breast cancer that has spread or cannot be removed by surgery or radiation, and your tumor is ER-positive and/or PR-positive. We plan to enroll 80 participants.

Study design
This is an interventional study comparing two treatment combinations. It plans to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, measuring objective response, is assessed for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07405801

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Hoffmann-La Roche
~80 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:InavolisibRibociclibFulvestrantPlacebo

At a glance

Recruiting sites
54 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Confirmed Objective Response (cORR)
Measured over Up to approximately 2 years

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaChromosome 8p

Where it's being run

54 sites across 24 states
South Dakota5
France5
Spain5
Argentina4
Poland4
South Korea4
Germany3
Lombardy3

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: CO46274 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as \>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)
Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen
Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Exclusion

Metaplastic breast cancer
Radiotherapy within 2 weeks before randomization
Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible
Any history of leptomeningeal disease or carcinomatous meningitis

What this trial measures

  • Percentage of Participants With Confirmed Objective Response (cORR)Up to approximately 2 years