Trial Title:
A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer
NCT ID:
NCT05945927
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab emtansine
Description:
Trastuzumab emtansine will be administered as per local clinical practice and local
labeling.
Arm group label:
Participants with HER2-positive Advanced Breast Cancer
Other name:
T-DM1
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.
Criteria for eligibility:
Study pop:
Participants with a diagnosis of HER2-positive advanced breast cancer will be included in
this trial.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anyang Tumor Hosptial
Address:
City:
Anyang City
Zip:
455000
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Country:
China
Status:
Recruiting
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences.
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Beijing Hospital; Internal Medicine-Oncology
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Active, not recruiting
Facility:
Name:
the First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu City
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center
Address:
City:
Guangzhou City
Zip:
510120
Country:
China
Status:
Recruiting
Facility:
Name:
Sun yat-sen University Cancer Center; Internal Medicine of Oncology
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Withdrawn
Facility:
Name:
The Affiliated Cancer Hospital of Guizhou Medical University
Address:
City:
Guiyang
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Facility:
Name:
Anhui Province Cancer Hospital
Address:
City:
Hefei City
Zip:
230031
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
529030
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital Of Shandong First Medical University
Address:
City:
Jinan City
Zip:
250014
Country:
China
Status:
Recruiting
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Withdrawn
Facility:
Name:
Dongyang People's Hospital
Address:
City:
Jinhua
Country:
China
Status:
Recruiting
Facility:
Name:
The Third Hospital of Nanchang
Address:
City:
Nanchang City
Zip:
330009
Country:
China
Status:
Recruiting
Facility:
Name:
Nanjing Gulou Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Facility:
Name:
Guangxi Cancer Hospital of Guangxi Medical University
Address:
City:
Nanning City
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nantong
Zip:
226001
Country:
China
Status:
Recruiting
Facility:
Name:
Ningbo No.2 Hospital
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Facility:
Name:
China Medical University (CMU) First Affiliated Hospital
Address:
City:
Shenyang City
Zip:
110001
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center
Address:
City:
Shenzhen City
Zip:
518127
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Tianjin Cancer Hospital; Department of Breast Oncology
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Cancer Hospital Affliated to Xinjiang Medical University
Address:
City:
Urumqi City
Zip:
830011
Country:
China
Status:
Recruiting
Facility:
Name:
Weifang People's Hospital
Address:
City:
Weifang City
Zip:
261041
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Address:
City:
Wuhan
Zip:
430023
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
Yibin Second People's Hospital
Address:
City:
Yibin
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Zhejiang
Zip:
310022
Country:
China
Status:
Recruiting
Start date:
September 13, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05945927
