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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 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
2026-05-18
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 (22)
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
Lanzhou, Gansu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Wenzhou Medical University Affiliated Second Hospital
Wenzhou, Zhejiang, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China
Chongqing Cancer Hospital
Chongqing, China
Zhujiang Hospital, Southern Medical University
Guangzhou, China
Guizhou Provincial People's Hospital
Guiyang, China
Hainan Provincial Peoples Hospital
Haikou, China
Harbin Medical University Cancer Hospital
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Shandong Provincial Hospital
Jinan, China
Jiangxi Cancer Hospital
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
Taizhou Hospital of Zhejiang Province
Taizhou, China
Weifang People's Hospital
Weifang, China
Hubei Cancer Hospital
Wuhan, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, China
Subei People's Hospital of Jiangsu province
Yangzhou, China