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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
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

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University First Hospital
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BeijingChinaRecruiting
Peking University Third Hospital
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BeijingChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaRecruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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ChengduChinaRecruiting
Chongqing Cancer Hospital
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ChongqingChinaRecruiting
The First Affiliated Hospital, Chongqing Medical University
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ChongqingChinaRecruiting
Guangdong Provincial Traditional Chinese Medicine Hospital
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GuangzhouChinaRecruiting
Sun Yat-sen Memorial Hospital
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GuangzhouChinaRecruiting
Zhujiang Hospital, Southern Medical University
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GuangzhouChinaRecruiting
Guizhou Provincial People's Hospital
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GuiyangChinaRecruiting
Hainan Provincial Peoples Hospital
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HaikouChinaRecruiting
Harbin Medical University Cancer Hospital
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HarbinChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaRecruiting
Shandong Provincial Hospital
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JinanChinaRecruiting
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
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LanzhouChinaRecruiting
Luoyang Central Hospital
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LuoyangChinaRecruiting
Jiangxi Cancer Hospital
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NanchangChinaRecruiting
Jiangsu Province Hospital
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NanjingChinaRecruiting
Zhongshan Hospital,Fudan University
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ShanghaiChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Liaoning Cancer Hospital & Institute
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ShenyangChinaRecruiting
The Fourth Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
Shanxi Provincial Cancer Hospital
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TaiyuanChinaRecruiting
Taizhou Hospital of Zhejiang Province
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TaizhouChinaRecruiting
Weifang People's Hospital
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WeifangChinaRecruiting
Wenzhou Medical University Affiliated Second Hospital
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WenzhouChinaRecruiting
Hubei Cancer Hospital
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WuhanChinaRecruiting
The First Affiliated hospital of Xiamen University
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XiamenChinaRecruiting
The First Affiliated Hospital of Xian Jiao Tong University
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Xi'anChinaRecruiting
Subei People's Hospital of Jiangsu province
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YangzhouChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
Zhongshan City People's Hospital
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ZhongshanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.