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 now · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT07405801

Run by

Hoffmann-La Roche

People needed

80

Starts

2026-04-07

Expected to finish

2030-02-26

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Avera Cancer Institute - Marshall — Marshall, Minnesota, United States (enrolling)
• Avera Cancer Institute - Aberdeen — Aberdeen, South Dakota, United States (enrolling)
• Avera Cancer Institute - Mitchell — Mitchell, South Dakota, United States (enrolling)
• Avera Cancer Institute - Pierre, SD — Pierre, South Dakota, United States (enrolling)
• Avera Cancer Institute — Sioux Falls, South Dakota, United States (enrolling)
• AMG Oncology and Hematology Avera Cancer Institute - Yankton — Yankton, South Dakota, United States (enrolling)
• Inst. Alexander Fleming — Buenos Aires, Argentina (enrolling)
• Centro Oncologico Korben — Caba, Argentina (enrolling)
• Centro Médico Fleischer — Capital Federal, Argentina (enrolling)
• Sanatorio de la Mujer — Rosario, Argentina (enrolling)
• Hospital Santa Rita de Cassia Vitoria — Vitória, Espírito Santo, Brazil (enrolling)
• Hospital Brasilia — Brasília, Federal District, Brazil (enrolling)
• ICTR Curitiba — Curitiba, Paraná, Brazil (enrolling)
• Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo, Brazil (enrolling)
• CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital — Chicoutimi, Quebec, Canada (enrolling)
• McGill University — Montreal, Quebec, Canada (enrolling)
• Centre Oscar Lambret — Lille, France (enrolling)
• Centre Leon Berard — Lyon, France (enrolling)
• Institut Paoli Calmettes — Marseille, France (enrolling)
• Institut Régional du Cancer de Montpellier — Montpellier, France (enrolling)
• Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) — Toulouse, France (enrolling)
• Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin — Aachen, Germany (enrolling)
• Universitätsklinik Tübingen — Tübingen, Germany (enrolling)
• Istituto Nazionale Tumori Irccs Fondazione g. PASCALE — Naples, Campania, Italy (enrolling)
• IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola — Meldola, Emilia-Romagna, Italy (enrolling)

Full record on ClinicalTrials.gov

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