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RECRUITING
NCT07347600

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

View on ClinicalTrials.gov

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

DRUG

Inavolisib

Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

DRUG

Palbociclib

Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

DRUG

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