This trial is active, not recruiting.

Condition breast cancer
Treatment genomic signature
Sponsor Institut Paoli-Calmettes
Start date April 2007
End date May 2015
Trial size 375 participants
Trial identifier NCT00912080, SA02/IPC 2006-003


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose screening
Patients who have a "good signature" for the genomic analysis. They will receive the standard chemotherapy.
genomic signature
genomic signature analysis

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.
time frame: 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.
time frame: 6 weeks
Overall survival.
time frame: 5 years

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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)

Additional Information

Official title Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.
Principal investigator Jean-Marc EXTRA, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Institut Paoli-Calmettes.