Clinical trial NCT00912080: Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer
Official title: Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: genomic signature
lymph nodes
no metastases
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 375
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: Time between collection for the genomic signature study and the beginning of the chemotherapy.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: Overall survival.
timeFrame: 5 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon BERARD
city: Marseille
country: France
facility: Institut PAOLI-CALMETTES
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
city: Toulon
country: France
facility: Chu Font-Pre
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean-Marc EXTRA, MD
role: PRINCIPAL_INVESTIGATOR
References: