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

July 30, 2012 updated by: Centre Oscar Lambret

Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annemasse, France, 74 107
        • Intercommunal Hospital
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59020
        • Hôpital Saint Vincent
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • THONON Les BAINS, France, 74 203
        • Geroges PIANTA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Blood sampling
Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy
Procedure: BIOPSY
Biopsy at the moment of inclusion, before neoadjuvant chemotherapy
Procedure: SURGERY
Surgery after neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation with node invasion
Time Frame: 6 months
6 months
Correlation with basal, luminal phenotypes, HER2 status or hormonal status
Time Frame: 6 months
6 months
Correlation with the response measured by ultrasound after chemotherapy
Time Frame: After 3 and 5 months
After 3 and 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: BONNETERRE Jacques, MD, PhD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPAM 2006-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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