Last updated 9 days ago
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
80 patients around the world
Available in Spain, United States, Belgium, Argentina
Hoffmann-La Roche
10Research sites
80Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting.Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines.Confirmation of biomarker eligibility: presence of >= 1 study-eligible PIK3CA mutation.Life expectancy of > 6 months.Ability, in the investigator's judgment, and willingness to comply with all study-related procedures, including completion of patient-reported outcomes.
- Metaplastic breast cancer.Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting.Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes.Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting.Requirement for daily supplemental oxygen.Symptomatic active lung disease, including pneumonitis.
Sites
Centro Oncológico Korben
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Centro Oncológico de Excelencia - COE San Juan
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Hospital Privado de Córdoba
Recruiting
CENEIT Oncológicos. Centro Especializado en Investigación y Tratamientos Oncológicos
Recruiting
CITIO - Centro de Infusión, Tratamiento e Investigación Oncológica
Recruiting
Renati Innovation S.A.P.I. de C.V., Onkimia
Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Recruiting
StudyoptINAVO
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07368998
