Last updated 8 days ago
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
60 patients around the world
Available in Brazil
Hoffmann-La Roche
3Research sites
60Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- 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.
- 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, 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.
Sites
Hospital Araújo Jorge
Recruiting
Hospital de Câncer de Pernambuco
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT07054190
