Clinical trial · Observational
Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with HER2+ Breast Cancer
Real-world Study on Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with Metastatic or Unresectable HER2-positive Breast Cancer: a French Ambispective Multicentre 2 Year-follow-up Cohort Study
NCT05149014CI-TRIAL-00081102completedClinicalTrials.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)
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.
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 |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
- timeFrame
- 2 years following the start of administration of Trastuzumab deruxtecan
- description
- The primary endpoint is the percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female adult patient (age ≥ 18 years); * Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and: * previously treated by compassionate trastuzumab deruxtecan (ATU group), or * previously treated or planned to be treated by trastuzumab deruxtecan (Enhertu®), upon the investigator's decision (Post-Marketing authorization group); * Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive. Exclusion Criteria: \- Previous participation in an interventional clinical trial with trastuzumab deruxtecan
References
Publications (0)
Data not yet available
No reference posted for this study.