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

Breast Cancer Clinical Trial

— SA02  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00912080
• Other study ID #: SA02/IPC 2006-003
• Status: Active, not recruiting
• Phase: N/A
• First received: May 29, 2009
• Last updated: March 19, 2013
• Start date: April 2007
• Est. completion date: May 2015

Study information

• Verified date: March 2013
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 375
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• genomic signature
genomic signature analysis

Locations

Country	Name	City	State
France	Centre Léon BERARD	Lyon
France	Institut PAOLI-CALMETTES	Marseille
France	Centre Antoine LACASSAGNE	Nice
France	Chu Font-Pre	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time between collection for the genomic signature study and the beginning of the chemotherapy.		6 weeks	No
Secondary	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	No
Secondary	Overall survival.		5 years	No

External Links

•   official site of the sponsor