Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Hoffmann-La Roche (Voir sur ClinicalTrials)
avril 2025
mai 2032
08 juin 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Chayma BOUSRIH | 17/06/2026 06:15:07 | Contact (sur clinicalTrials) | ||
Critères
Tous
- 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 Criteria:
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or
within the time frame in which contraception is required
- Metaplastic breast cancer
- Any prior systemic therapy for locally advanced unresectable or metastatic 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
- Any active bowel inflammation
- 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