Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Not Applicable
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00293865
- Lead Sponsor
- Institut Cancerologie de l'Ouest
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 203
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method false negatives
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Centre Hospitalier
🇫🇷La roche sur yon, France
Centre Alexis Vautrin
🇫🇷Nancy, France
Centre René Gauducheau
🇫🇷Saint Herblain, France
Hospîtal
🇫🇷Angers, France
Institut Bergonié
🇫🇷Bordeaux, France
Hospital
🇫🇷Poitiers, France
Centre Oscar Lambret
🇫🇷Lille, France
Institut Paoli Calmette
🇫🇷Marseille, France
centre Léon Berard
🇫🇷Lyon, France
Hôpital Tenon
🇫🇷Paris, France
Hopital Européen Georges Pompidou
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugène Marquis
🇫🇷Rennes, France
Centre Claudius Regaud
🇫🇷Toulouse, France
Hopital Lariboisière
🇫🇷Paris, France