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Sponsor: Hoffmann-La Roche
Conditions: Locally Advanced Breast Cancer, Metastatic Breast Cancer
Interventions: Inavolisib, Palbociclib, Fulvestrant
Countries: China
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
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
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Changchun, Jilin, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Beijing, China
- Chengdu, China
- Chongqing, China
- Guangzhou, China
- Guangzhou, China
- Guangzhou, China
- Guiyang, China
- Haikou, China
- Harbin, China
- Hefei, China
- Jinan, China
- Luoyang, China
- Nanchang, China
- Nanjing, China
- Shanghai, China
- Shanghai, China
- Shenyang, China
- Taiyuan, China
- Taizhou, China
- Weifang, China
- Wuhan, China
- Xi'an, China
- Yangzhou, China