Clinical trial · Interventional
Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy
Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy
NCT00911911CI-TRIAL-00105398SPAMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIOPSY | Procedure | — | UNRESOLVED |
| Blood sampling | Procedure | — | UNRESOLVED |
| SURGERY | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FEC 100 + TAXOTERE
- description
- FEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE TAXOTERE 100 mg/m²/cycle 1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100
- interventionNames
- Procedure: Blood sampling
- Procedure: BIOPSY
- Procedure: SURGERY
Primary outcomes (1)
- measure
- Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
- timeFrame
- 6 months
Secondary outcomes (3)
- measure
- Correlation with node invasion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged more than 18 years * Histologically proven breast carcinoma * Neo-adjuvant chemotherapy with anthracyclines and/or taxanes * No prior chemotherapy * Written informed consent Exclusion Criteria: * Metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.