NCT00911911

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2012

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

May 22, 2009

Last Update Submit

March 12, 2026

Conditions

Breast Cancer

Keywords

Breast cancerNeo-adjuvant chemotherapyProteomicHistological response

Outcome Measures

Primary Outcomes (1)

  • Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff

    6 months

Secondary Outcomes (3)

  • 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

Study Arms (1)

FEC 100 + TAXOTERE

EXPERIMENTAL

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 samplingProcedure: BIOPSYProcedure: SURGERY

Interventions

Blood samplingPROCEDURE

Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy

FEC 100 + TAXOTERE
BIOPSYPROCEDURE

Biopsy at the moment of inclusion, before neoadjuvant chemotherapy

FEC 100 + TAXOTERE
SURGERYPROCEDURE

Surgery after neoadjuvant chemotherapy

FEC 100 + TAXOTERE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged more than 18 years
  • Histologically proven breast carcinoma
  • Neo-adjuvant chemotherapy with anthracyclines and/or taxanes
  • No prior chemotherapy
  • Written informed consent

You may not qualify if:

  • Metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Intercommunal Hospital

Annemasse, 74 107, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Hopital Saint Vincent

Lille, 59020, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Geroges PIANTA Hospital

Thonon-les-Bains, 74 203, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen CollectionBiopsySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, Surgical

Study Officials

  • BONNETERRE Jacques, MD, PhD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2009

First Posted

June 3, 2009

Study Start

February 22, 2007

Primary Completion

January 1, 2009

Study Completion

January 16, 2012

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

FR(5)