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Recruiting NCT07347600

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

Conditions: Locally Advanced Breast Cancer Metastatic Breast Cancer

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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 Criteria: * 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
Interventions
Inavolisib
DRUG
Palbociclib
DRUG
Fulvestrant
DRUG
Locations 17
China (17)
Peking University First Hospital
Beijing
Peking University Third Hospital
Beijing
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu
Chongqing Cancer Hospital
Chongqing
Zhujiang Hospital, Southern Medical University
Guangzhou
Harbin Medical University Cancer Hospital
Harbin
Shandong Provincial Hospital
Jinan
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
Lanzhou , Gansu
Jiangxi Cancer Hospital
Nanchang
Jiangsu Province Hospital
Nanjing
Fudan University Shanghai Cancer Center
Shanghai
Shanxi Provincial Cancer Hospital
Taiyuan
Taizhou Hospital of Zhejiang Province
Taizhou
Weifang People's Hospital
Weifang
Wenzhou Medical University Affiliated Second Hospital
Wenzhou , Zhejiang
Hubei Cancer Hospital
Wuhan
Subei People's Hospital of Jiangsu province
Yangzhou
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.01.2026
Completion date
09.09.2029
Registry ID
NCT07347600
Source
clinicaltrials.gov
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