Status:
COMPLETED
Axillary Sentinel Lymph Node Detection in Breast Cancers > 2 cm
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
PHRC 2007: financial support
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of fals...
Detailed Description
Axillary node extension is one of the major prognostic factors in breast cancer. Axillary dissection of Berg level I and II nodes is the validated method to obtain information on lymph node invasion, ...
Eligibility Criteria
Inclusion
- Female, age ≥ 18 years
- Patient with invasive unifocal breast cancer with tumor size \> 2 cm at initial examination (clinical examination and/or imaging)
- Preoperative histological diagnosis of infiltrating mammary carcinoma
- No lymph node at clinical examination
- No treatment for this cancer before surgery
- Mandatory affiliation with a social security system
- Written, signed informed consent
Exclusion
- No invasive breast cancer
- Breast tumor =\< 2 cm
- Preoperative histological diagnosis other than infiltrating mammary carcinoma
- Multifocal breast cancer
- Inflammatory breast cancer
- Metastatic cancer
- History of homolateral breast surgery
- History of allergic disorders
- History of homolateral breast cancer
- Difficult follow-up
- Pregnant or lactating woman
- Previous inclusion in the trial
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT00636467
Start Date
March 1 2008
End Date
September 1 2011
Last Update
September 26 2012
Active Locations (22)
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1
Centre Paul Papin
Angers, France, 49033
2
Institut Bergonié
Bordeaux, France, 33076
3
CH Boulogne sur Mer
Boulogne-sur-Mer, France, 62321
4
CH Calais
Calais, France, 62107