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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00911911
First received: May 22, 2009
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Breast Cancer
Procedure: Blood sampling
Procedure: BIOPSY
Procedure: SURGERY

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation with node invasion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation with basal, luminal phenotypes, HER2 status or hormonal status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation with the response measured by ultrasound after chemotherapy [ Time Frame: After 3 and 5 months ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: January 2007
Study Completion Date: July 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00911911     History of Changes
Obsolete Identifiers: NCT00959673
Other Study ID Numbers: SPAM 2006-10
Study First Received: May 22, 2009
Last Updated: July 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 14, 2014