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This study is a post-marketing, observational, multicenter, prospective study. It will investigate the the safety and effectiveness of T-DM1 in the Chinese population in real-world clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with HER2-positive Advanced Breast Cancer | Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab emtansine | Drug | Trastuzumab emtansine will be administered as per local clinical practice and local labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Up to approximately 1 year from index date |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world Progression Free Survival (rwPFS) | From the index date to the date of first progression of disease as recorded in rwTR or death due to any reason, whichever occurs first (up to approximately 1 year from index date) | |
| Time-to-treatment Discontinuation (TTD) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anyang Tumor Hosptial | Anyang | 455000 | China | |||
| Affiliated Hospital of Hebei University |
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|
| Up to approximately 1 year from index date |
| Percentage of Participants Exposed to T-DM1 by Line of Therapy | Up to approximately 1 year from index date |
| Percentage of Participants Exposed to T-DM1 by Dosage | Up to approximately 1 year from index date |
| Percentage of Participants Exposed to T-DM1 by Dose Intensity | Up to approximately 1 year from index date |
| Percentage of Participants Exposed to T-DM1 by Duration | Up to approximately 1 year from index date |
| Percentage of Participants Exposed to Prior and Concomitant Medication by WHODrug Anatomical Therapeutic Chemical (ATC) Classification System | Up to approximately 1 year from index date |
| Percentage of Participants Exposed to Prior and Concomitant Surgery/Procedure by Medical Dictionary for Regulatory Activities (MedDRA) | Up to approximately 1 year from index date |
| Baoding |
| China |
| Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | 100021 | China |
| Beijing Hospital | Beijing | 100730 | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| West China Hospital of Sichuan University | Chengdu | 610041 | China |
| Fujian Cancer Hospital | Fuzhou | 350014 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | 510120 | China |
| The Affiliated Cancer Hospital of Guizhou Medical University | Guiyang | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Anhui Province Cancer Hospital | Hefei | 230031 | China |
| Jiangmen Central Hospital | Jiangmen | 529030 | China |
| The First Affiliated Hospital Of Shandong First Medical University | Jinan | 250014 | China |
| Dongyang People's Hospital | Jinhua | China |
| The Third Hospital of Nanchang | Nanchang | 330009 | China |
| Nanjing Gulou Hospital | Nanjing | China |
| Guangxi Cancer Hospital of Guangxi Medical University | Nanning | 530021 | China |
| Affiliated Hospital of Nantong University | Nantong | 226001 | China |
| Ningbo No.2 Hospital | Ningbo | China |
| China Medical University (CMU) First Affiliated Hospital | Shenyang | 110001 | China |
| Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center | Shenzhen | 518127 | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | 030013 | China |
| Tianjin Cancer Hospital | Tianjin | China |
| Cancer Hospital Affliated to Xinjiang Medical University | Ürümqi | 830011 | China |
| Weifang People's Hospital | Weifang | 261041 | China |
| Union Hospital of Tongji Medical College, Dept. of Cancer Center | Wuhan | 430023 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | 710061 | China |
| Yibin Second People's Hospital | Yibin | China |
| Zhejiang Cancer Hospital | Zhejiang | 310022 | 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 |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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