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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00911911
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Blood sampling Procedure: BIOPSY Procedure: SURGERY

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy
Study Start Date : January 2007
Primary Completion Date : January 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Correlation with node invasion [ Time Frame: 6 months ]
  2. Correlation with basal, luminal phenotypes, HER2 status or hormonal status [ Time Frame: 6 months ]
  3. Correlation with the response measured by ultrasound after chemotherapy [ Time Frame: After 3 and 5 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911911


Locations
France
Intercommunal Hospital
Annemasse, France, 74 107
Centre Oscar Lambret
Lille, France, 59020
Hopital Saint Vincent
Lille, France, 59020
Centre Henri Becquerel
Rouen, France, 76038
Geroges PIANTA Hospital
THONON Les BAINS, France, 74 203
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: BONNETERRE Jacques, MD, PhD Centre Oscar Lambret
More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00911911     History of Changes
Obsolete Identifiers: NCT00959673
Other Study ID Numbers: SPAM 2006-10
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by Centre Oscar Lambret:
Breast cancer
Neo-adjuvant chemotherapy
Proteomic
Histological response

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases