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

Hoffmann-La Roche30 sites in 1 country178 target enrollmentSeptember 13, 2023

ConditionsBreast Cancer

InterventionsTrastuzumab emtansine

DrugsTrastuzumab emtansine

Overview

Phase: Not Applicable
Intervention: Trastuzumab emtansine
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 178
Locations: 30
Primary Endpoint: Percentage of Participants with Adverse Events
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 13, 2023

End Date

August 30, 2025

Last Updated

6 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Arms & Interventions

Participants with HER2-positive Advanced Breast Cancer

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

Intervention: Trastuzumab emtansine

Outcomes

Primary Outcomes

Percentage of Participants with Adverse Events

Time Frame: Up to approximately 1 year from index date

Secondary Outcomes

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))