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 · NCT07405801 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
58 locations listed across 5 US states.
- 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
- Instytut "Centrum Zdrowia Matki Polki" - ?ód?, Poland
- Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin - Aachen, Germany
- Hospital Clinic Barcelona - Barcelona, Spain
- Bialostockie Centrum Onkologii - Bialystok, Poland
- Inst. Alexander Fleming - Buenos Aires, Argentina
- Centro Oncologico Korben - Caba, Argentina
- Centro Médico Fleischer - Capital Federal, Argentina
- Städtisches Klinikum Dessau - Dessau, Germany
- Soon Chun Hyang University Cheonan Hospital - Dongnam-gu, Cheonan-si, South Korea
- Universitätsklinikum Essen - Essen, Germany
- Hospital Universitario Clínico San Cecilio - Granada, Spain
- Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde - Guadalajara, Mexico
- Nationales Centrum für Tumorerkrankungen (NCT) - Heidelberg, Germany
- Leicester Royal Infirmary - Leicester, United Kingdom
- Centre Oscar Lambret - Lille, France
- Royal Free Hospital - London, United Kingdom
- COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej - Lublin, Poland
- Centre Leon Berard - Lyon, France
- Hospital Ramon y Cajal - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Christie Hospital Nhs Trust - Manchester, United Kingdom
- Institut Paoli Calmettes - Marseille, France
- Institut Régional du Cancer de Montpellier - Montpellier, France
- Gachon University Gil Medical Center - Namdong-Gu, South Korea
- Sanatorio de la Mujer - Rosario, Argentina
- Seoul National University Bundang Hospital - Seongnam-si, South Korea
- Seoul National University Hospital - Seoul, South Korea
- Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) - Toulouse, France
- Universitätsklinik Tübingen - Tübingen, Germany
- Hospital Clinico Universitario de Valencia - Valencia, Spain
- Dolno?l?skie Centrum Onkologii - Wroc?aw, Poland
- ICO L'Hospitalet - L'Hospitalet de Llobregat, Barcelona, Spain
- 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
- Hospital Santa Rita de Cassia Vitoria - Vitória, Espírito Santo, Brazil
- Hospital Brasilia - Brasília, Federal District, Brazil
- 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
- Ottawa General Hospital - Ottawa, Ontario, Canada
- Sunnybrook Health Science Centre - Toronto, Ontario, Canada
- Ictrials Pesquisa e Desenvolvimento - Curitiba, Paraná, Brazil
- CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital - Chicoutimi, Quebec, Canada
- McGill University - Montreal, Quebec, Canada
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda - São Paulo, São Paulo, Brazil