RecruitingNCT07347600

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 Prospective 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)


Sponsor

Hoffmann-La Roche

Enrollment

500 participants

Start Date

Jan 21, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is observing how well a drug called inavolisib works in real-world clinical practice for women with a specific type of advanced breast cancer — hormone receptor-positive, HER2-negative breast cancer that has a PIK3CA mutation and has stopped responding to hormone therapy. **You may be eligible if...** - You have been diagnosed with locally advanced or metastatic HR+/HER2- breast cancer that stopped responding to hormonal therapy - Your cancer has a PIK3CA mutation confirmed by approved testing - You are receiving inavolisib for the first time as part of your standard care **You may NOT be eligible if...** - Inavolisib is not indicated for your condition according to prescribing guidelines - You are not receiving this treatment as standard of care - Your doctor believes follow-up or participation is not feasible for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInavolisib

Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

DRUGPalbociclib

Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

DRUGFulvestrant

Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.


Locations(17)

Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)

Lanzhou, Gansu, China

Wenzhou Medical University Affiliated Second Hospital

Wenzhou, Zhejiang, China

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

Zhujiang Hospital, Southern Medical University

Guangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Shandong Provincial Hospital

Jinan, China

Jiangxi Cancer Hospital

Nanchang, China

Jiangsu Province Hospital

Nanjing, China

Fudan University Shanghai Cancer Center

Shanghai, 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

Subei People's Hospital of Jiangsu province

Yangzhou, China

View Full Details on ClinicalTrials.gov

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NCT07347600


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