Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Blood sampling
- Conditions
- Breast Cancer
- Sponsor
- Centre Oscar Lambret
- Enrollment
- 66
- Locations
- 5
- Primary Endpoint
- Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
- Status
- Completed
- Last Updated
- last month
Overview
Brief Summary
The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.
Investigators
Eligibility Criteria
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
Arms & Interventions
FEC 100 + TAXOTERE
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
Intervention: Blood sampling
FEC 100 + TAXOTERE
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
Intervention: BIOPSY
FEC 100 + TAXOTERE
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
Intervention: SURGERY
Outcomes
Primary Outcomes
Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
Time Frame: 6 months
Secondary Outcomes
- Correlation with node invasion(6 months)
- Correlation with basal, luminal phenotypes, HER2 status or hormonal status(6 months)
- Correlation with the response measured by ultrasound after chemotherapy(After 3 and 5 months)