Real-world use of inavolisib in advanced breast cancer with a PIK3CA mutation
Observes how inavolisib works in adults with advanced PIK3CA-mutated breast cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Beijing, Changchun, Chengdu, Chongqing, Guangzhou, Guiyang, Haikou, Harbin, Hefei, Jinan, Lanzhou, Luoyang, Nanchang, Nanjing, Shanghai, Shenyang, Shijiazhuang, Taiyuan, Taizhou, Weifang, Wenzhou, Wuhan, Xi'an, Xiamen, Yangzhou, Zhengzhou, and Zhongshan, ChinaSee the 32 sites
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- Peking University Third HospitalBeijing, ChinaTaking people
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples HospitalChengdu, ChinaTaking people
- Chongqing Cancer HospitalChongqing, ChinaTaking people
- The First Affiliated Hospital, Chongqing Medical UniversityChongqing, ChinaTaking people
- Guangdong Provincial Traditional Chinese Medicine HospitalGuangzhou, ChinaTaking people
- Sun Yat-sen Memorial HospitalGuangzhou, ChinaTaking people
- Zhujiang Hospital, Southern Medical UniversityGuangzhou, ChinaTaking people
- Guizhou Provincial People's HospitalGuiyang, ChinaTaking people
- Hainan Provincial Peoples HospitalHaikou, ChinaTaking people
- Harbin Medical University Cancer HospitalHarbin, ChinaTaking people
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaTaking people
- Shandong Provincial HospitalJinan, ChinaTaking people
- Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)Lanzhou, ChinaTaking people
- Luoyang Central HospitalLuoyang, ChinaTaking people
- Jiangxi Cancer HospitalNanchang, ChinaTaking people
- Jiangsu Province HospitalNanjing, ChinaTaking people
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaTaking people
- Liaoning Cancer Hospital & InstituteShenyang, ChinaTaking people
- The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Shanxi Provincial Cancer HospitalTaiyuan, ChinaTaking people
- Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaTaking people
- Weifang People's HospitalWeifang, ChinaTaking people
- Wenzhou Medical University Affiliated Second HospitalWenzhou, ChinaTaking people
- Hubei Cancer HospitalWuhan, ChinaTaking people
- The First Affiliated Hospital of Xian Jiao Tong UniversityXi'an, ChinaTaking people
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaTaking people
- Subei People's Hospital of Jiangsu provinceYangzhou, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
- Zhongshan City People's HospitalZhongshan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07347600
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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.