Status:
COMPLETED
Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.
Eligibility Criteria
Inclusion
- Age \> 18 years
- Previous conservative surgical biopsy
- Secondary pathological diagnosis of infiltrative cancer
- No clinically involved axillary node (N0)
- No previous neoadjuvant treatment
- Performance status European Cancer Conference (ECCO) Grade ≤ 1
- Patient's written informed consent to participate in the study according to French law
- Surgeon must have performed its learning curve
Exclusion
- Lack of infiltrative breast carcinoma (in situ) pT4d \> N0
- Breast cancer relapse
- Pregnancy
- Known patent blue allergy
- Indication for radical or partial mastectomy
- Patient unable to understand the trial
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00293865
Start Date
March 1 2006
End Date
March 1 2012
Last Update
April 19 2016
Active Locations (17)
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1
Hospîtal
Angers, France, 49000
2
Institut Bergonié
Bordeaux, France, 33076
3
Hospital
Brest, France, 29000
4
Centre Hospitalier
La Roche-sur-Yon, France, 85000