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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
genomic signature
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring genomic signature, lymph nodes, no metastases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Centre Léon BERARD
  • Institut PAOLI-CALMETTES
  • Centre Antoine LACASSAGNE
  • Chu Font-Pre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

good signature

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time between collection for the genomic signature study and the beginning of the chemotherapy.
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.
Overall survival.

Full Information

First Posted
May 29, 2009
Last Updated
March 19, 2013
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT00912080
Brief Title
Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer
Acronym
SA02
Official Title
Utilisation of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer: A Prospective Cohort Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
genomic signature, lymph nodes, no metastases

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
good signature
Arm Type
Experimental
Arm Description
Patients who have a "good signature" for the genomic analysis. They will receive the standard chemotherapy.
Intervention Type
Genetic
Intervention Name(s)
genomic signature
Intervention Description
genomic signature analysis
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Time between collection for the genomic signature study and the beginning of the chemotherapy.
Time Frame
6 weeks
Title
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
Title
Overall survival.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc EXTRA, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon BERARD
City
Lyon
Country
France
Facility Name
Institut PAOLI-CALMETTES
City
Marseille
Country
France
Facility Name
Centre Antoine LACASSAGNE
City
Nice
Country
France
Facility Name
Chu Font-Pre
City
Toulon
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.institutpaolicalmettes.fr/
Description
official site of the sponsor

Learn more about this trial

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

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