Last updated 17 days ago
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
450 patients around the world
Available in Brazil, United States
Hoffmann-La Roche
10Research sites
450Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
Centro Regional Integrado de Oncologia - CRIO
Recruiting
Hospital Santa Rita
Recruiting
Hospital Araújo Jorge
Recruiting
Hospital Do Cancer de Londrina
Recruiting
Hospital de Câncer de Pernambuco
Recruiting
Vencer e Oncoclinica - Oncoclínica Oncologistas Associados
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária
Recruiting
StudyINAVO123
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06790693
