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

NCT ID: NCT00911911

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Breast cancer Neo-adjuvant chemotherapy Proteomic Histological response

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

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

BIOPSY

Intervention Type PROCEDURE

Biopsy at the moment of inclusion, before neoadjuvant chemotherapy

SURGERY

Intervention Type PROCEDURE

Surgery after neoadjuvant chemotherapy

Interventions

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Blood sampling

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

Intervention Type PROCEDURE

BIOPSY

Biopsy at the moment of inclusion, before neoadjuvant chemotherapy

Intervention Type PROCEDURE

SURGERY

Surgery after neoadjuvant chemotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BONNETERRE Jacques, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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Intercommunal Hospital

Annemasse, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Hopital Saint Vincent

Lille, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Geroges PIANTA Hospital

Thonon-les-Bains, , France

Site Status

Countries

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France

Other Identifiers

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SPAM 2006-10

Identifier Type: -

Identifier Source: org_study_id

NCT00959673

Identifier Type: -

Identifier Source: nct_alias