Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer

Study Overview
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Brief Summary
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Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100). The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor. Patients who have a good signature for the genomic analysis will receive the standard chemotherapy. Primary objective: To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies. Secondary Objectives: Overall survival. Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery. Histological and seric proteomic exploratory studies.

Official Title
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Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: genomic signature


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged between 18 and 70 Patient with life condition < 2 (WHO scale) One-sided breast adenocarcinoma with a histological evidence (all type) Clinical presentation which allowed a complete surgery with healthy limits Absence of metastasis detectable at clinical examination or radiology Histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (N > 1) The beginning of the chemotherapy within 6 weeks following the primary surgery Exclusion Criteria: All metastatic affect Tumor classed >= T4a: cutaneous invasion, deep adherence, inflammatory breast All chemotherapy, hormonotherapy or radiotherapy before surgery Tumoral residue not removed Any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled History of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: good signature<br>Patients who have a good signature for the genomic analysis. They will receive the standard chemotherapy. | Genetic: genomic signature<br>* genomic signature analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of metastasis free survival at 5 years of the patients who had a good genomic signature. The metastasis free survival is defined by the time between the histological diagnosis of the breast cancer and the apparition of the first metastasis. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between collection for the genomic signature study and the beginning of the chemotherapy. |  | 6 weeks | 
| Seric and histological proteomic exploratory studies with SELDI-TOF MS to: search correlation with histo-clinical or/and molecular parameter and to identify one or few proteic signature with a prognosis value. |  | 6 weeks | 
| Overall survival. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genomic signature, lymph nodes, no metastases