Clinical trial · Observational
Level of HER2-neu Gene Amplification an Response to Trastuzumab
Retrospective Study of the Level of HER2-neu Gene Amplification as Predictive Factor of Response in Patients With HER2-positive Advanced Breast Cancer Treated With Trastuzumab Containing Regimens.
NCT00874146CI-TRIAL-00003867unknownClinicalTrials.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)
Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.
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 |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescent in-situ hybridization (FISH) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- HER2-positive advanced breast cancer
- interventionNames
- Genetic: Fluorescent in-situ hybridization (FISH)
Primary outcomes (1)
- measure
- Association of tumor cytogenetic paremeters with TTP and OS.
- timeFrame
- one year
Secondary outcomes (1)
- measure
- Association of cytogenetic parameters evalued by FISH test and patients' characteristics.
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive Exclusion Criteria: * HER2-negative advanced breast cancer Pretreatment with trastuzumab
References
Publications (0)
Data not yet available
No reference posted for this study.