Clinical trial · Observational
Tyrosine Kinase Inhibitors (TKIs) in Trastuzumab Emtansine (T-DM1) Resistant HER2-positive Metastatic Breast Cancer: A Real-world Study
Tyrosine Kinase Inhibitors (TKIs) Based Therapy in Trastuzumab Emtansine (T-DM1) Resistant HER2-positive Metastatic Breast Cancer: A Real-world Study
NCT05231863CI-TRIAL-00056435unknownClinicalTrials.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 is a real world study to evaluate the efficacy and safety of tyrosine kinase inhibitors after T-DM1 progression.
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 |
|---|---|---|---|
| TKIs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational Group
- description
- Patients receive TKIs after T-DM1 progression.
- interventionNames
- Drug: TKIs
Primary outcomes (2)
- 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.
- measure
- Objective Response Rate (ORR)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female and 18-70 years old * Metastatic or locally recurrent HER2-positive breast cancer * Patients received TKIs-based therapy after T-DM1 failure in treatment for metastasis * Complete and accurate medical data Exclusion Criteria: \- Incomplete medical data
References
Publications (0)
Data not yet available
No reference posted for this study.