Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer (SN-FNAC)
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|ClinicalTrials.gov Identifier: NCT00909441|
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : February 10, 2015
Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
Objectives of the study:
1. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy.
- Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy.
- Evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.
Number of patients:
N = 300
Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes.
From February 2009 to February 2012 - 3 years
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Invasive Breast Cancer||Procedure: Sentinel Lymph Node Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-institutional Prospective Study Furthering the Treatment of Breast Cancer|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||December 2012|
Experimental: SNB + ALND
Intervention: Sentinel Lymph Node Biopsy followed by Axillary Node Dissection.
Procedure: Sentinel Lymph Node Biopsy
Sentinel node biopsy is a technique in which a radioactive isotope is injected in the breast, with or without blue dye. These substances will then migrate and concentrate in the first nodes in the axilla that drain the breast: The sentinel nodes. These nodes (usually one to four nodes) are then evaluated for the presence of cancer cells.
- The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. [ Time Frame: 4-7 months ]
- Evaluate the accuracy of clinical evaluation and ultrasound examination in determining the presence of residual disease following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. [ Time Frame: 3-6 months ]
- Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy [ Time Frame: 4-7 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909441
|Centre de recherche du Centre hospitalier de l'Université de Montréal|
|Montréal, Quebec, Canada, H2W 1T7|
|Principal Investigator:||Jean-François Boileau, MD FRCSC||Centre hospitalier de l'Université de Montréal (CHUM)|