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
Recruiting · NCT07347600 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
30 locations listed.
- 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
- Sun Yat-sen Memorial Hospital - Guangzhou, China
- Zhujiang Hospital, Southern Medical University - Guangzhou, China
- Guangdong Provincial Traditional Chinese Medicine Hospital - 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
- Luoyang Central Hospital - Luoyang, China
- Jiangxi Cancer Hospital - Nanchang, China
- Jiangsu Province Hospital - Nanjing, China
- Fudan University Shanghai Cancer Center - Shanghai, China
- Zhongshan Hospital Fudan University - Shanghai, China
- Liaoning cancer Hospital & Institute - Shenyang, 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
- Henan Cancer Hospital - Zhengzhou, China
- Zhongshan City People's Hospital - Zhongshan, China
- The First Affiliated Hospital of Xiamen University - Xiamen, Fujian, China
- 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