Breast Cancer
Conditions
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.
Interventions
DRUGTrastuzumab emtansine
Trastuzumab emtansine will be administered as per local clinical practice and local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events | Up to approximately 1 year from index date |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-treatment Discontinuation (TTD) | 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 Dosage | 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) |
| Percentage of Participants Exposed to T-DM1 by Duration | 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 |
| Percentage of Participants Exposed to T-DM1 by Dose Intensity | Up to approximately 1 year from index date |
Countries
China
Outcome results
None listed