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

Breast Cancer Clinical Trial

— SPAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911911
• Other study ID #: SPAM 2006-10
• Status: Completed
• Phase: N/A
• First received: May 22, 2009
• Last updated: July 30, 2012
• Start date: January 2007
• Est. completion date: July 2009

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00959673

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Blood sampling
Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy
• BIOPSY
Biopsy at the moment of inclusion, before neoadjuvant chemotherapy
• SURGERY
Surgery after neoadjuvant chemotherapy

Locations

Country	Name	City	State
France	Intercommunal Hospital	Annemasse
France	Centre Oscar Lambret	Lille
France	Hopital Saint Vincent	Lille
France	Centre Henri Becquerel	Rouen
France	Geroges PIANTA Hospital	THONON Les BAINS

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff		6 months	No
Secondary	Correlation with node invasion		6 months	No
Secondary	Correlation with basal, luminal phenotypes, HER2 status or hormonal status		6 months	No
Secondary	Correlation with the response measured by ultrasound after chemotherapy		After 3 and 5 months	No