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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06790693Tipo: INTERVENTIONALInicio: 9 de abr de 2025Fin estimado: 30 de may de 2032

Oncología Endocrinología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Inavolisib

Participants will receive oral inavolisib once daily (QD).

drug

Placebo

Participants will receive oral placebo QD.

drug

CDK4/6i

Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.

drug

Letrozole

Participants will receive oral letrozole QD.

Ubicaciones

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

RECRUITING

Instituto de Oncologia de Rosario

Rosario, Argentina

RECRUITING

Centro Oncológico de Excelencia

San Juan, Argentina

RECRUITING

Centro Oncologico Korben

Caba, Argentina

RECRUITING

Centro Médico Fleischer

Capital Federal, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

Contactos

Reference Study ID Number: WO45654 https://forpatients.roche.com/

CONTACT

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. Only)

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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