Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy Cancer Patients With Radiologically Positive Axillary Lymph Nodes (VSNBNAC)
This study has been completed.
Sponsor:
Gangnam Severance Hospital
Information provided by (Responsible Party):
Sung Gwe Ahn, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01622478
First received: June 15, 2012
Last updated: August 14, 2012
Last verified: August 2012
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Purpose
Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic drainage thus causing lower SLN identification rate and higher false negative rate. Further, the response of NAC can be different in each lymph nodes. It is doubtful whether SLNB can accurately predict axillary lymph node (ALN) status after NAC. The aim of this study to determine the identification rate, the false-negative rate, and the accuracy of SLNB after NAC for node positive breast cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: Sentinel lymph node biopsy Drug: Neoadjuvant chemotherapy Procedure: complete axillary lymph node dissection Procedure: positron emission tomography and ultrasonogram |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients With Radiologically Positive Axillary Lymph Nodes |
Resource links provided by NLM:
Further study details as provided by Gangnam Severance Hospital:
| Enrollment: | 120 |
| Study Start Date: | December 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Clinically node-positive patients before NAC
Patients with clinically positive lymph node receiving neoadjuvant chemotherapy
|
Procedure: Sentinel lymph node biopsy
Sentinel lymph node biopsy after neoadjuvant chemotherapy for the patients with clinically positive-nodes at presentation
Drug: Neoadjuvant chemotherapy
Neoadjuvant chemotherapy for breast cancer patients with clinically positive-node at initial diagnosis
Procedure: complete axillary lymph node dissection
Complete axillary lymph node dissection after sentinel node biopsy for estimation of false-negative rate of sentinel node biopsy
Procedure: positron emission tomography and ultrasonogram
Routine evaluation of axillary nodal status using 18-fluorodeoxyglucose positron emission tomography and ultrasonogram before and after chemotherapy
|
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Advanced breast cancer patients with node-positive proved in preoperative imaging study
Criteria
Inclusion Criteria:
- Advanced breast cancer patients with node-positive proved in preoperative imaging study
- ECOG status 0-1
Exclusion Criteria:
- No previous cancer history
- No previous chemotherapy history
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sung Gwe Ahn, Research Fellow, Breast Cancer Center, Gangnam Severance Hospital |
| ClinicalTrials.gov Identifier: | NCT01622478 History of Changes |
| Other Study ID Numbers: | GNSBCC001 |
| Study First Received: | June 15, 2012 |
| Last Updated: | August 14, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Gangnam Severance Hospital:
|
sentinel lymph node biopsy neoadjuvant chemotherapy breast cancer |
locally advanced breast cancer positive axillary lymph node negative conversion |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013