Tests inavolisib with standard drugs for advanced breast cancer with a PIK3CA mutation
Tests inavolisib with hormone and CDK4/6 drugs in adults with PIK3CA-mutated breast cancer.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Key facts
- Where
- Bergamo, Bologna, Bolzano, Caserta, Meldola, Milan, Misterbianco, Modena, Naples, Novara, Pisa, Rome, Rozzano, Terni, and Tricase, ItalySee the 17 sites
- Phase
- Phase 3
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Central Hospital Of BolzanoBolzano, ItalyTaking people
- Azienda Ospedaliera Sant'Anna E San Sebastiano Di CasertaCaserta, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Humanitas Istituto Clinico Catanese S.p.A.Misterbianco, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Azienda Unita Sanitaria Locale Toscana Nord OvestPisa, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Azienda Ospedaliera S Maria Di TerniTerni, ItalyTaking people
- Pia Fondazione Di Culto E Religione Card G PanicoTricase, ItalyTaking 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
- NCT06790693EU 2024-516162-11-00
- Record updated
- 4 November 2026
- Original description
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).Read full original descriptionShow less
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-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; Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines; Documented HER2-negative tumor according to ASCO/CAP guidelines; De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment; Participants who have bilateral breast cancers which are both HR-positive and HER2-negative; Confirmation of biomarker eligibility; Consent to provide fresh or archival tumor tissue specimen; Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Adequate hematologic and organ function within 14 days prior to initiation of study treatment.
Exclusion: Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer; Prior hematopoietic stem cell or bone marrow transplantation; Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment; Metaplastic breast cancer; Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes; Any history of leptomeningeal disease or carcinomatous meningitis; Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible; Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye; Symptomatic active lung disease; History of or active inflammatory bowel disease; Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required; Any active bowel inflammation.