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Clinical Trials in China / NCT07347600
Recruiting Observational

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 · tracked via the Priya Life Science China tracker
Sponsor
Hoffmann-La Roche
Phase
Observational
Started
2026-01-21
Last updated
2026-09-08

Condition(s) studied

Locally Advanced Breast CancerMetastatic Breast Cancer

Investigational drug(s) / intervention(s)

InavolisibPalbociclibFulvestrant

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy * Participants must receive the treatment of inavolisib for the first time * PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\] by testing of blood or tumor tissue prior to the initiation of inavolisib Exclusion Criteria: * Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant * Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling * At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine) Lanzhou Gansu Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
Wenzhou Medical University Affiliated Second Hospital Wenzhou Zhejiang Recruiting
Peking University First Hospital Beijing China Recruiting
Peking University Third Hospital Beijing China Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu China Recruiting
Chongqing Cancer Hospital Chongqing China Recruiting
Sun Yat-sen Memorial Hospital Guangzhou China Recruiting
Zhujiang Hospital, Southern Medical University Guangzhou China Recruiting
Guangdong Provincial Traditional Chinese Medicine Hospital Guangzhou China Recruiting
Guizhou Provincial People's Hospital Guiyang China Recruiting
Hainan Provincial Peoples Hospital Haikou China Recruiting
Harbin Medical University Cancer Hospital Harbin China Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei China Recruiting
Shandong Provincial Hospital Jinan China Recruiting
Luoyang Central Hospital Luoyang China Recruiting
Jiangxi Cancer Hospital Nanchang China Recruiting
Jiangsu Province Hospital Nanjing China Recruiting
Fudan University Shanghai Cancer Center Shanghai China Recruiting
Zhongshan Hospital Fudan University Shanghai China Recruiting
Liaoning cancer Hospital & Institute Shenyang China Recruiting
Shanxi Provincial Cancer Hospital Taiyuan China Recruiting
Taizhou Hospital of Zhejiang Province Taizhou China Recruiting
Weifang People's Hospital Weifang China Recruiting
Hubei Cancer Hospital Wuhan China Recruiting
The First Affiliated Hospital of Xian Jiao Tong University Xi'an China Recruiting
Subei People's Hospital of Jiangsu province Yangzhou China Recruiting
Henan Cancer Hospital Zhengzhou China Recruiting
Zhongshan City People's Hospital Zhongshan China Recruiting

On this site

📄 Ibrance (palbociclib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07347600 on ClinicalTrials.gov ↗ ← All trials in China