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

Roche

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab emtansine

Study type: Observational

Funder types: Industry

Identifiers

NCT05945927

ML44675

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

178 participants in 1 patient group

Participants with HER2-positive Advanced Breast Cancer

Description:

Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year.

Treatment:

Drug: Trastuzumab emtansine