Clinical trial · Observational
Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib
Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment
NCT06135194CI-TRIAL-00071491unknownClinicalTrials.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)
To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
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 (0)
[]Primary outcomes (1)
- measure
- Central neryous system Progression Free Survival，CNS-PFS
- timeFrame
- 3years
- description
- The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions
Secondary outcomes (3)
- measure
- Overall Response Rate (ORR)for intracranial and extracranial lesions
- timeFrame
- 3years
- description
- Percentage of patients with CompleteResponse (CR) and partial response (PartialResponse (PR)
- measure
- Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions
- timeFrame
- 3years
- description
- Percentage of patients with complete response, partial response, and StableDisease (SD)≥6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: (1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records Exclusion Criteria: * Has uncontrolled or significant cardiovascular disease * Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening * Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
References
Publications (0)
Data not yet available
No reference posted for this study.