Clinical trial · Observational
T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer
A Retrospective Study for Evaluation of Real-world Efficacy and Safety of T-DM1 in HER2-positive Locally-advanced Unresectable or Metastatic Breast Cancer
- 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 is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of T-DM1 in metastatic/relapsed HER2-positive breast cancer as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review \& Assessment Service (HIRA). The medical records in approximately 1,000 patients of HER2-positive locally-advanced unresectable or metastatic breast cancer, who have received Kadcyla(Trastuzumab Emtansine, T-DM1) previously, will be collected.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression free Survival, PFS
- timeFrame
- Until September 30, 2019
- description
- Time from the start of T-DM1 to disease progression or death from any cause
- measure
- Incidence of adverse events
- timeFrame
- Until September 30, 2019
- description
- Number (percentage) of subjects reporting adverse events
Secondary outcomes (6)
- measure
- Time to Next Treatment, TTNT
- timeFrame
- Until September 30, 2019
- description
- Time from the end of T-DM1 to institution of next systemic therapy
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥19 years at the time of study registration 2. Participants must have histologically confirmed HER2-positive breast cancer 3. Locally advanced unresectable or metastatic patients 4. Patients who have received T-DM1 therapy between Aug 2017 and December 2018 under the Korea National Health Insurance System Exclusion Criteria: • Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System
References
Publications (0)
Data not yet available