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
- Angers, Lille, Montpellier, Paris, Plerin, Poitiers, Rennes Cedex, Rouen Cedex, Saint-Cloud, Saint-Herblain Cedex, Toulouse Cedex 9, and Villejuif, FranceSee the 12 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women and men with advanced breast cancer that is hormone receptor-positive, HER2-negative and has a PIK3CA mutation, who have not yet had treatment for advanced disease.
- Age
- 18 years or older.
- Sex
- Women and men can join.
- Disease stage
- Advanced breast cancer that is hormone receptor-positive and HER2-negative, either found as advanced from the start or relapsed after at least 2 years of earlier hormone therapy and at least 1 year disease-free. The disease must be measurable on scans.
- Earlier treatment
- No earlier systemic treatment for locally advanced unresectable or metastatic breast cancer. Relapsed disease needs at least 2 years of earlier hormone therapy without progression during it.
- Biomarker or test result
- The tumor must have a PIK3CA mutation (biomarker eligibility must be confirmed). The tumor must be HER2-negative and estrogen receptor-positive and/or progesterone receptor-positive. Tumor tissue must be provided.
Main reasons for not taking part
- Pregnant or breastfeeding
- Metaplastic breast cancer
- Type 2 diabetes needing ongoing treatment, or any history of Type 1 diabetes
- Known untreated or active brain or spinal cord (CNS) metastases, or leptomeningeal disease
- Earlier stem cell or bone marrow transplant
Read by machine on 12 November 2026.
Where in France
- Institut de Cancerologie de L'OuestAngers, FranceTaking people
- Centre Oscar LambretLille, FranceTaking people
- Centre De Cancerologue Du Grand MontpellierMontpellier, FranceTaking people
- Institut CurieParis, FranceTaking people
- CARIO Centre Armoricain de Radiotherapie d'Imagerie medicale et d'OncologiePlerin, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Centre De Lutte Contre Le Cancer Eugene MarquisRennes Cedex, FranceTaking people
- Centre Henri BecquerelRouen Cedex, FranceTaking people
- Institut CurieSaint-Cloud, FranceTaking people
- Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranceTaking people
- Oncopole Claudius RegaudToulouse Cedex 9, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.