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

NCT05945927

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Trastuzumab emtansine

Countries: China

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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

Locations (30)

Anyang, China
Baoding, China
Beijing, China
Beijing, China
Changchun, China
Chengdu, China
Fuzhou, China
Guangzhou, China
Guiyang, China
Harbin, China
Hefei, China
Jiangmen, China
Jinan, China
Jinhua, China
Nanchang, China
Nanjing, China
Nanning, China
Nantong, China
Ningbo, China
Shenyang, China
Shenzhen, China
Taiyuan, China
Tianjin, China
Ürümqi, China
Weifang, China
Wuhan, China
Wuhan, China
Xi'an, China
Yibin, China
Zhejiang, China