N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07405801

Registry updated: 2026-10-06
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

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).

Interventions

  • Inavolisib (Drug)
    Inavolisib will be administered as per the schedule mentioned in the protocol.
  • Ribociclib (Drug)
    Ribociclib will be administered as per the schedule mentioned in the protocol.
  • Fulvestrant (Drug)
    Fulvestrant will be administered as per the schedule mentioned in the protocol.
  • Placebo (Drug)
    Placebo will be administered as per the schedule mentioned in the protocol.

Eligibility criteria

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

Conditions

Breast Cancer

Locations

  • Los Angeles Cancer Network - Anaheim — Anaheim, California, United States
  • Stanford Cancer Institute — Palo Alto, California, United States
  • Cancer Specialists of North Florida — Jacksonville, Florida, United States
  • Avera Cancer Institute - Marshall — Marshall, Minnesota, United States
  • Avera Cancer Institute - Aberdeen — Aberdeen, South Dakota, United States
  • Avera Cancer Institute - Mitchell — Mitchell, South Dakota, United States
  • Avera Cancer Institute - Pierre, SD — Pierre, South Dakota, United States
  • Avera Cancer Institute — Sioux Falls, South Dakota, United States
  • AMG Oncology and Hematology Avera Cancer Institute - Yankton — Yankton, South Dakota, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Inst. Alexander Fleming — Buenos Aires, Argentina
  • Centro Oncologico Korben — Caba, Argentina
  • Centro Médico Fleischer — Capital Federal, Argentina
  • Sanatorio de la Mujer — Rosario, Argentina
  • Hospital Santa Rita de Cassia Vitoria — Vitória, Espírito Santo, Brazil
  • Hospital Brasilia — Brasília, Federal District, Brazil
  • Ictrials Pesquisa e Desenvolvimento — Curitiba, Paraná, Brazil
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo, Brazil
  • Ottawa General Hospital — Ottawa, Ontario, Canada
  • Sunnybrook Health Science Centre — Toronto, Ontario, Canada
  • CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital — Chicoutimi, Quebec, Canada
  • McGill University — Montreal, Quebec, Canada
  • Centre Oscar Lambret — Lille, France
  • Centre Leon Berard — Lyon, France
  • Institut Paoli Calmettes — Marseille, France
  • Institut Régional du Cancer de Montpellier — Montpellier, France
  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) — Toulouse, France
  • Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin — Aachen, Germany
  • Städtisches Klinikum Dessau — Dessau, Germany
  • Universitätsklinikum Essen — Essen, Germany
  • Nationales Centrum für Tumorerkrankungen (NCT) — Heidelberg, Germany
  • Universitätsklinik Tübingen — Tübingen, Germany
  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE — Naples, Campania, Italy
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola — Meldola, Emilia-Romagna, Italy
  • Università Campus Bio-Medico di Roma — Rome, Lazio, Italy
  • Asst Papa Giovanni XXIII — Bergamo, Lombardy, Italy
  • Ospedale San Raffaele — Milan, Lombardy, Italy
  • Irccs Istituto Nazionale Dei Tumori (Int) — Milan, Lombardy, Italy
  • Instituto Nacional De Cancerologia — Distrito Federal, Mexico CITY (federal District), Mexico
  • Centro de Investigacion Clinica de Oaxaca — Oaxaca City, Oaxaca, Mexico
  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Mexico
  • Instytut "Centrum Zdrowia Matki Polki" — ?ód?, Poland
  • Bialostockie Centrum Onkologii — Bialystok, Poland
  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej — Lublin, Poland
  • Dolno?l?skie Centrum Onkologii — Wroc?aw, Poland
  • Soon Chun Hyang University Cheonan Hospital — Dongnam-gu, Cheonan-si, South Korea
  • Gachon University Gil Medical Center — Namdong-Gu, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • ICO L'Hospitalet — L'Hospitalet de Llobregat, Barcelona, Spain
  • Hospital Clinic Barcelona — Barcelona, Spain
  • Hospital Universitario Clínico San Cecilio — Granada, Spain
  • Hospital Ramon y Cajal — Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
  • Leicester Royal Infirmary — Leicester, United Kingdom
  • Royal Free Hospital — London, United Kingdom
  • Christie Hospital Nhs Trust — Manchester, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record