A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

An Observational Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Second- or Later-Line Therapy in Chinese Patients With HER2 Positive Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945927
• Other study ID #: ML44675
• Status: Recruiting
• Start date: September 13, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: ML44675 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. and Canada)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab emtansine
Trastuzumab emtansine will be administered as per local clinical practice and local labeling.

Locations

Country	Name	City	State
China	Anyang Tumor Hosptial	Anyang City
China	Affiliated Hospital of Hebei University	Baoding
China	Beijing Hospital; Internal Medicine-Oncology	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences.	Beijing
China	the First Hospital of Jilin University	Changchun
China	West China Hospital of Sichuan University	Chengdu City
China	Fujian Cancer Hospital	Fuzhou
China	Sun yat-sen University Cancer Center; Internal Medicine of Oncology	Guangzhou
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center	Guangzhou City
China	The Affiliated Cancer Hospital of Guizhou Medical University	Guiyang
China	Harbin Medical University Cancer Hospital	Harbin
China	Anhui Province Cancer Hospital	Hefei City
China	Jiangmen Central Hospital	Jiangmen
China	Qilu Hospital of Shandong University	Jinan
China	The First Affiliated Hospital Of Shandong First Medical University	Jinan City
China	Dongyang People's Hospital	Jinhua
China	The Third Hospital of Nanchang	Nanchang City
China	Nanjing Gulou Hospital	Nanjing
China	Guangxi Cancer Hospital of Guangxi Medical University	Nanning City
China	Affiliated Hospital of Nantong University	Nantong
China	Ningbo No.2 Hospital	Ningbo
China	China Medical University (CMU) First Affiliated Hospital	Shenyang City
China	Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center	Shenzhen City
China	Shanxi Provincial Cancer Hospital	Taiyuan
China	Tianjin Cancer Hospital; Department of Breast Oncology	Tianjin
China	Cancer Hospital Affliated to Xinjiang Medical University	Urumqi City
China	Weifang People's Hospital	Weifang City
China	Hubei Cancer Hospital	Wuhan
China	Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center	Wuhan
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	Yibin Second People's Hospital	Yibin
China	Zhejiang Cancer Hospital	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events		Up to approximately 1 year from index date
Secondary	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)
Secondary	Time-to-treatment Discontinuation (TTD)		Up to approximately 1 year from index date
Secondary	Percentage of Participants Exposed to T-DM1 by Line of Therapy		Up to approximately 1 year from index date
Secondary	Percentage of Participants Exposed to T-DM1 by Dosage		Up to approximately 1 year from index date
Secondary	Percentage of Participants Exposed to T-DM1 by Dose Intensity		Up to approximately 1 year from index date
Secondary	Percentage of Participants Exposed to T-DM1 by Duration		Up to approximately 1 year from index date
Secondary	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
Secondary	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