Clinical trial · Observational
Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
NCT03521245CI-TRIAL-00053869unknownClinicalTrials.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)
The purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-HER2 therapy with Trastuzumab.
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 |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| RNA sequencing | Other | — | UNRESOLVED |
| Transcriptome analysis | Other | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Trastuzumab monotherapy
- description
- Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
- interventionNames
- Other: RNA sequencing
- Other: Transcriptome analysis
- Drug: Trastuzumab
- label
- Chemotherapy plus Trastuzumab
- description
- Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
- interventionNames
- Other: RNA sequencing
- Other: Transcriptome analysis
- Drug: Trastuzumab
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Tumor response by RECIST v1.1 or pathological response according to Chevallier system
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * adult females * histologically confirmed HER2-positive breast cancer * available FFPE samples of breast cancer tissue * patients treated with Trastuzumab alone or in combination(s) with other regimens of chemotherapy with known outcome according to RECIST 1.1 * stage II or more * patients who have signed an informed consent Exclusion Criteria: * less than 70% of intact tumor cells in available FFPE samples
References
Publications (0)
Data not yet available
No reference posted for this study.