Clinical trial · Observational
Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study
NCT07108595CI-TRIAL-00093226completedClinicalTrials.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)
Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T- Dxd | Drug | Trastuzumab Deruxtecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Observational Group
- description
- Patients receive T-DXd
- interventionNames
- Drug: T- Dxd
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 2 years
- description
- Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Secondary outcomes (1)
- measure
- The Number of Participants Who Experienced Adverse Events (AE)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. female patients aged ≥18 years; 2. histologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH+) or HER2-low (IHC 1+ or IHC 2+/FISH-) disease; 3. radiologically confirmed recurrent or metastatic disease; 4. completion of ≥2 cycles of T-DXd therapy; 5. comprehensive medical documentation; 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤3; 7. measurable target lesions according to RECIST 1.1 Exclusion Criteria: 1. history of interstitial lung disease 2. incomplete medical records 3. concurrent malignancies; 4. pregnancy or lactation 5. psychiatric disorders compromising treatment adherence
References
Publications (0)
Data not yet available
No reference posted for this study.