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Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Advanced or Metastatic Breast Cancer
Led by Hoffmann-La Roche · Updated on 2026-08-11
500
Participants Needed
29
Research Sites
36 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an inavolisib-based treatment in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. This study focuses on patients who have completed adjuvant endocrine therapy and aims to observe real-world outcomes in China. Participants will receive inavolisib, with administration decided by their physician following local clinical practice and labeling. Additional drugs such as palbociclib and fulvestrant may also be given at the physicians discretion, and treatment is observed for up to approximately 36 months. Throughout the study, participants will be monitored for various outcomes including progression-free survival, tumor response, treatment duration, and safety. Data will be collected on adverse events, dose modifications, and time to next treatments. Participation involves regular assessments to track treatment effects and overall health over the study period.
CONDITIONS
Brief Title
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Research Team
R
Reference Study ID Number: ML46361 https://forpatients.roche.com/ No attachments to email below.
F
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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