Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer (SA02)

Institut Paoli-Calmettes

Status: Unknown

Conditions: Breast Cancer

Treatments: Genetic: genomic signature

Study type: Interventional

Funder types: Other

Identifiers

NCT00912080

SA02/IPC 2006-003

Details and patient eligibility

About

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.

Enrollment: 375 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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375 participants in 1 patient group

good signature

Experimental group

Description:

Patients who have a "good signature" for the genomic analysis. They will receive the standard chemotherapy.

Treatment:

Genetic: genomic signature