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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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Rozpoznanie oporności na leczenie hormonalne, z mutacją PIK3CA, rakiem piersi z dodatnim receptorem hormonalnym i ujemnym HER2, po nawrocie
  • Pierwsze zastosowanie leku inavolisib
  • Potwierdzona mutacja PIK3CA zatwierdzonym testem

✗ Disqualifies

  • Brak wskazania do leczenia inavolisibem według ulotki leku
  • Leczenie poza standardem opieki dla tego rozpoznania
  • Inne okoliczności utrudniające udział lub obserwację pacjenta

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 12, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (23)

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

Lanzhou, China

The First Hospital of Jilin University

Changchun, China

Wenzhou Medical University Affiliated Second Hospital

Wenzhou, 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

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

Jiangxi Cancer Hospital

Nanchang, China

Jiangsu Province Hospital

Nanjing, China

Fudan University Shanghai Cancer Center

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

Trial contact

Reference Study ID Number: ML46361 https://forpatients.roche.com/

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.