A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Recruiting · NCT07054190 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Stage IV (metastatic) BC
- Inflammatory BC (cT4d)
- Bilateral invasive 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, and 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
Where it is running
34 locations listed across 3 US states.
- Los Angeles Cancer Network - Los Angeles, California, United States
- Community Clinical Trials - Orange, California, United States
- West Cancer Center - Germantown, Tennessee, United States
- West Virginia University - Morgantown, West Virginia, United States
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona - Barcelona, Spain
- Hospital Clinic Barcelona - Barcelona, Spain
- Das Brustzentrum - Berlin, Germany
- HELIOS Klinikum Berlin-Buch - Berlin, Germany
- Hospital Aleman de Buenos Aires - Buenos Aires, Argentina
- Centro Médico Fleischer - Buenos Aires, Argentina
- Centro Oncologico Korben - Ciudad Autonoma Buenos Aires, Argentina
- Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden - Dresden, Germany
- Kliniken Essen-Mitte - Essen, Germany
- Universitätsklinikum Heidelberg - Heidelberg, Germany
- Hospital General Universitario Gregorio Marañon - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise - Paderborn, Germany
- Hospital Clinico Universitario de Salamanca - Salamanca, Spain
- HELIOS Klinikum Schwerin - Schwerin, Germany
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital, Yonsei University Health System - Seoul, South Korea
- Asan Medical Center. - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Hospital Universitario Virgen Macarena - Seville, Spain
- Hospital Clínico Universitario de Valencia - Valencia, Spain
- BC Cancer - Vancouver - Vancouver, British Columbia, Canada
- Hospital Araujo Jorge - Goiânia, Goiás, Brazil
- Sunnybrook Odette Cancer Centre - Toronto, Ontario, Canada
- Hospital do Cancer de Pernambuco - HCP - Recife, Pernambuco, Brazil
- Centre Hospitalier de l'Universite de Montreal (CHUM) - Montreal, Quebec, Canada
- Jewish General Hospital - Montreal, Quebec, Canada
- McGill University Health Center - Montreal, Quebec, Canada
- Irmandade Da Santa Casa de Misericordia de Porto Alegre - Porto Alegre, Rio Grande do Sul, Brazil
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda - São Paulo, São Paulo, Brazil