NCT00912080UnknownNot Applicable
Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.
Institut Paoli-Calmettes4 sites in 1 country375 target enrollmentStarted: April 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 375
- Locations
- 4
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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.
Time Frame: 5 years
Secondary Outcomes
- 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)
Investigators
Study Sites (4)
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