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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
Sponsor: Hoffmann-La Roche
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.
Official title: A Prospective Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2026-01-21
Completion Date
2029-09-09
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
Inavolisib
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Palbociclib
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Fulvestrant
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Locations (9)
Wenzhou Medical University Affiliated Second Hospital
Wenzhou, Zhejiang, China
Peking University First Hospital
Beijing, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China
Zhujiang Hospital, Southern Medical University
Guangzhou, China
Jiangxi Cancer Hospital
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Fudan University Shanghai Cancer Center
Shanghai, China
Hubei Cancer Hospital
Wuhan, China
Subei People's Hospital of Jiangsu province
Yangzhou, China