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Clinical Trials in the UK / NCT07405801
Recruiting Phase 2

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

NCT07405801 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2026-04-07
Last updated
2026-09-08

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

InavolisibRibociclibFulvestrantPlacebo

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

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

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

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
Los Angeles Cancer Network - Anaheim Anaheim California Recruiting
Stanford Cancer Institute Palo Alto California Recruiting
Cancer Specialists of North Florida Jacksonville Florida Recruiting
Avera Cancer Institute - Marshall Marshall Minnesota Recruiting
Avera Cancer Institute - Aberdeen Aberdeen South Dakota Recruiting
Avera Cancer Institute - Mitchell Mitchell South Dakota Recruiting
Avera Cancer Institute - Pierre, SD Pierre South Dakota Recruiting
Avera Cancer Institute Sioux Falls South Dakota Recruiting
AMG Oncology and Hematology Avera Cancer Institute - Yankton Yankton South Dakota Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Inst. Alexander Fleming Buenos Aires Argentina Recruiting
Centro Oncologico Korben Caba Argentina Recruiting
Centro Médico Fleischer Capital Federal Argentina Recruiting
Sanatorio de la Mujer Rosario Argentina Recruiting
Hospital Santa Rita de Cassia Vitoria Vitória Espírito Santo Recruiting
Hospital Brasilia Brasília Federal District Recruiting
Ictrials Pesquisa e Desenvolvimento Curitiba Paraná Recruiting
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda São Paulo São Paulo Recruiting
Ottawa General Hospital Ottawa Ontario Recruiting
Sunnybrook Health Science Centre Toronto Ontario Recruiting
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital Chicoutimi Quebec Recruiting
McGill University Montreal Quebec Recruiting
Centre Oscar Lambret Lille France Recruiting
Centre Leon Berard Lyon France Recruiting
Institut Paoli Calmettes Marseille France Recruiting
Institut Régional du Cancer de Montpellier Montpellier France Recruiting
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) Toulouse France Recruiting
Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin Aachen Germany Recruiting
Städtisches Klinikum Dessau Dessau Germany Recruiting
Universitätsklinikum Essen Essen Germany Recruiting
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg Germany Recruiting
Universitätsklinik Tübingen Tübingen Germany Recruiting
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE Naples Campania Recruiting
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola Meldola Emilia-Romagna Recruiting
Università Campus Bio-Medico di Roma Rome Lazio Recruiting
Asst Papa Giovanni XXIII Bergamo Lombardy Recruiting
Ospedale San Raffaele Milan Lombardy Recruiting
Irccs Istituto Nazionale Dei Tumori (Int) Milan Lombardy Recruiting
Instituto Nacional De Cancerologia Distrito Federal Mexico CITY (federal District) Recruiting
Centro de Investigacion Clinica de Oaxaca Oaxaca City Oaxaca Recruiting

+ 18 more sites — see the full list on the official registry below.

On this site

📄 Kisqali (ribociclib) drug profile →

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07405801 on ClinicalTrials.gov ↗ ← All trials in the UK