Clinical trial · Observational
Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients
Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients
- 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)
Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity. Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.
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 |
|---|---|---|---|
| Gene mutation analyses and FISH | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observation
- description
- Breast cancer patients treated with Herceptin-based therapy
- interventionNames
- Genetic: Gene mutation analyses and FISH
Primary outcomes (1)
- measure
- Association of a specific biomarker with response to Herceptin-based therapy
- timeFrame
- Response after two months of treatment
Secondary outcomes (1)
- measure
- Association of a specific biomarker with time to progression survival and patient's characteristics
- timeFrame
- At the end of enrollment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Hystological diagnosis of breast cancer * Availability of tumor tissue * Availability to assess the response to Trastuzumab according to RECIST criteria * Availability of clinical data Exclusion Criteria: * Unavailability of tumor tissue * Impossibility to assess the response to Trastuzumab according to RECIST criteria
References
Publications (0)
Data not yet available