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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inavolisib | Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy will be observed for effectiveness and safety of inavolisib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inavolisib | Drug | Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-world Progression-free Survival (rwPFS) | From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately 36 months | |
| Real-world Time to Progression (rwTTP) | From index date to first occurrence of PD (up to approximately 36 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy in routine clinical practice in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: ML46361 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361003 | China | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Palbociclib | Drug | Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling. |
|
| Fulvestrant | Drug | Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling. |
|
| Number of Participants With Real-world Tumor Response (rwTR) to the Treatment | Up to approximately 36 months |
| Real-world Duration of Response (rwDoR) | From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months) |
| Real-world Time-to-treatment Discontinuation (rwTTD) | From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months) |
| Real-world Time to Next Treatment (rwTTNT) | From index date to new anti-cancer therapy (up to approximately 36 months) |
| Real-world Time to Chemotherapy (rwTTC) | From index date to date of chemotherapy initiation (up to approximately 36 months) |
| Treatment Duration of Inavolisib | Up to approximately 36 months |
| Total Dose of Inavolisib Received | Up to approximately 36 months |
| Number of Participants Who Experience Dose Modification, Including Missing Doses, Dose Interruption, Dose Reduction, or Early Discontinuation | Up to approximately 36 months |
| Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine) |
| Recruiting |
| Lanzhou |
| Gansu |
| 730050 |
| China |
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
| Wenzhou Medical University Affiliated Second Hospital | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| Peking University First Hospital | Recruiting | Beijing | 100034 | China |
| Peking University Third Hospital | Recruiting | Beijing | 100191 | China |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Recruiting | Chengdu | 610072 | China |
| Chongqing Cancer Hospital | Recruiting | Chongqing | 400030 | China |
| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | 510120 | China |
| Zhujiang Hospital, Southern Medical University | Recruiting | Guangzhou | 510280 | China |
| Guangdong Provincial Traditional Chinese Medicine Hospital | Recruiting | Guangzhou | 510335 | China |
| Guizhou Provincial People's Hospital | Recruiting | Guiyang | 550002 | China |
| Hainan Provincial Peoples Hospital | Recruiting | Haikou | 570311 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | 150081 | China |
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | 230022 | China |
| Shandong Provincial Hospital | Recruiting | Jinan | 250021 | China |
| Luoyang Central Hospital | Recruiting | Luoyang | 471000 | China |
| Jiangxi Cancer Hospital | Recruiting | Nanchang | 330006 | China |
| Jiangsu Province Hospital | Recruiting | Nanjing | 210029 | China |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | 200032 | China |
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | 200032 | China |
| Liaoning cancer Hospital & Institute | Recruiting | Shenyang | 110042 | China |
| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | 030013 | China |
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | 317000 | China |
| Weifang People's Hospital | Recruiting | Weifang | 261041 | China |
| Hubei Cancer Hospital | Recruiting | Wuhan | 430079 | China |
| The First Affiliated Hospital of Xian Jiao Tong University | Recruiting | Xi'an | China |
| Subei People's Hospital of Jiangsu province | Recruiting | Yangzhou | 225001 | China |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000723546 | inavolisib |
| C500026 | palbociclib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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