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
NCT07347600 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2026-05-18
Summary
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.
Conditions
- Locally Advanced Breast Cancer
- Metastatic Breast Cancer
Interventions
- DRUG
-
Inavolisib
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
- DRUG
-
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
- DRUG
-
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-21
- Primary Completion
- 2028-12-31
- Completion
- 2029-09-09
Countries
- China
Study Locations
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