A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer
- Registration Number
- NCT05945927
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 178
- Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer before the start of T-DM1 treatment
- Had prior treatment for breast cancer which must contain a taxane and trastuzumab
- Get the treatment of T-DM1 for the first time after diagnosis of breast cancer
- Patients not receiving treatment for HER2-positive breast cancer with T-DM1 according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling
- Has been previously treated with T-DM1 before current clinical visit
- Currently participating in any clinical trials
- Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with HER2-positive Advanced Breast Cancer Trastuzumab emtansine Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events Up to approximately 1 year from index date
- Secondary Outcome Measures
Name Time Method Time-to-treatment Discontinuation (TTD) 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 Duration 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 Dose Intensity 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 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)
Trial Locations
- Locations (30)
Union Hospital of Tongji Medical College, Dept. of Cancer Center
π¨π³Wuhan, China
Beijing Hospital
π¨π³Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
π¨π³Guangzhou City, China
Tianjin Cancer Hospital
π¨π³Tianjin, China
Anyang Tumor Hosptial
π¨π³Anyang City, China
Affiliated Hospital of Hebei University
π¨π³Baoding, China
Cancer Hospital Chinese Academy of Medical Sciences.
π¨π³Beijing, China
the First Hospital of Jilin University
π¨π³Changchun, China
West China Hospital of Sichuan University
π¨π³Chengdu City, China
Fujian Cancer Hospital
π¨π³Fuzhou, China
The Affiliated Cancer Hospital of Guizhou Medical University
π¨π³Guiyang, China
Harbin Medical University Cancer Hospital
π¨π³Harbin, China
Anhui Province Cancer Hospital
π¨π³Hefei City, China
Jiangmen Central Hospital
π¨π³Jiangmen, China
The First Affiliated Hospital Of Shandong First Medical University
π¨π³Jinan City, China
Dongyang People's Hospital
π¨π³Jinhua, China
The Third Hospital of Nanchang
π¨π³Nanchang City, China
Nanjing Gulou Hospital
π¨π³Nanjing, China
Guangxi Cancer Hospital of Guangxi Medical University
π¨π³Nanning, China
Affiliated Hospital of Nantong University
π¨π³Nantong, China
Ningbo No.2 Hospital
π¨π³Ningbo, China
China Medical University (CMU) First Affiliated Hospital
π¨π³Shenyang City, China
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
π¨π³Shenzhen City, China
Shanxi Provincial Cancer Hospital
π¨π³Taiyuan, China
Cancer Hospital Affliated to Xinjiang Medical University
π¨π³Urumqi City, China
Weifang People's Hospital
π¨π³Weifang City, China
Hubei Cancer Hospital
π¨π³Wuhan, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
π¨π³Xi'an, China
Yibin Second People's Hospital
π¨π³Yibin, China
Zhejiang Cancer Hospital
π¨π³Zhejiang, China