Clinical trial · Observational
A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer
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
NCT05945927CI-TRIAL-00096491completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab emtansine | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Trastuzumab emtansine
Primary outcomes (1)
- measure
- Percentage of Participants with Adverse Events
- timeFrame
- Up to approximately 1 year from index date
Secondary outcomes (8)
- measure
- Real-world Progression Free Survival (rwPFS)
- timeFrame
- 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)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.