NCT07347600Recruiting
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
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)
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 9 Jan 2026
- Start date
- Jan 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07347600
What you commit to
- Study type: Observational
- Planned participants: 500
- From Jan 2026 to the primary completion date, Dec 2028
- 32 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Chongqing Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital, Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Guangdong Provincial Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sun Yat-sen Memorial Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhujiang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guizhou Provincial People's Hospital Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| Hainan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Haikou | China | Recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine) Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| Luoyang Central Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Jiangxi Cancer Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Weifang People's Hospital Coordinator of this site? Confirm its status | Weifang | China | Recruiting |
| Wenzhou Medical University Affiliated Second Hospital Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The First Affiliated Hospital of Xian Jiao Tong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Subei People's Hospital of Jiangsu province Coordinator of this site? Confirm its status | Yangzhou | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Zhongshan City People's Hospital Coordinator of this site? Confirm its status | Zhongshan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.