Inavolisib added to ribociclib and fulvestrant for advanced breast cancer
Tests adding inavolisib to ribociclib and fulvestrant in adults with advanced breast cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Lille, Lyon, Marseille, Montpellier Cedex 5, Toulouse Cedex 9, and Villejuif, FranceSee the 6 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women and men with advanced HR-positive, HER2-negative breast cancer that has stopped responding to hormone therapy. The tumour must lack a PIK3CA mutation and have loss of chromosome 8p.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Breast cancer that has spread locally or to other parts of the body, and cannot be treated with surgery or radiation meant to remove all of the disease. The disease must be measurable on scans.
- Earlier treatment
- No earlier systemic treatment for advanced or metastatic breast cancer. The cancer must have grown during hormone-based treatment after surgery, or within 12 months after finishing it, with an aromatase inhibitor or tamoxifen.
- Biomarker or test result
- Tumour is estrogen receptor-positive and/or progesterone receptor-positive (at least 1% of tumour cells). Central lab testing must show no PIK3CA mutation and a loss of one copy of chromosome 8p.
Main reasons for not taking part
- Metaplastic breast cancer
- Radiotherapy within 2 weeks before randomization
- Needs chemotherapy at study entry, for example with visceral crisis
- Type 2 diabetes needing ongoing treatment, or any history of Type 1 diabetes
- Untreated or active brain metastases, or any history of leptomeningeal disease
Read by machine on 9 November 2026.
Where in France
- Centre Oscar LambretLille, FranceTaking people
- Centre Leon BerardLyon, FranceTaking people
- Institut Paoli-CalmettesMarseille, FranceTaking people
- Institut Regional Du Cancer De MontpellierMontpellier Cedex 5, FranceTaking people
- Oncopole Claudius RegaudToulouse Cedex 9, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07405801EU 2025-523013-28-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
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: 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); Metaplastic breast cancer; 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.