Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Blood sampling; Procedure: BIOPSY; Procedure: SURGERY

• Registration Number: NCT00911911
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-01
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Study Completion: 2009-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FEC 100 + TAXOTERE	Blood sampling	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
FEC 100 + TAXOTERE	SURGERY	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
FEC 100 + TAXOTERE	BIOPSY	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

Primary Outcome Measures

Name	Time	Method
Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Intercommunal Hospital; 🇫🇷 Annemasse, France

Hopital Saint Vincent; 🇫🇷 Lille, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Geroges PIANTA Hospital; 🇫🇷 THONON Les BAINS, France