A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07054190Tipo: INTERVENTIONALInicio: 9 de sept de 2025Fin estimado: 28 de sept de 2027

Traducción no disponible, mostrando original

Resumen

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
Documented Ki-67 score \>=5% as per local assessment
Confirmed PIK3CA mutation

Criterios de exclusión

Bilateral invasive BC
Inflammatory BC (cT4d)
Stage IV (metastatic) BC
History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

Intervenciones

drug

Inavolisib

Inavolisib will be administered as per the schedule specified in the arms

drug

Ribociclib

Ribociclib will be administered as per the schedule specified in the arms

drug

Letrozole

Letrozole will be administered as per the schedule specified in the arms

Ubicaciones

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

Contactos

Reference Study ID Number: BO45853 https://forpatients.roche.com/

CONTACT

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

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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