Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer
RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease.
PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer.
Drug: patent blue V dye
Procedure: conventional surgery
Procedure: radionuclide imaging
Procedure: sentinel lymph node biopsy
Radiation: Technetium Tc 99m human serum albumin colloid
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Sentinel Lymph Node Biopsy in the Assessment of Axillary Nodal Status in Operable Breast Cancer|
|Study Start Date:||December 1998|
- Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in women with resectable stage I or II breast cancer.
OUTLINE: Patients are stratified according to node status (positive vs negative).
Patients undergo lymphoscintigraphy, which consists of technetium Tc 99m human serum albumin colloid being injected near the tumor. Dynamic imaging using a gamma camera is performed for 20 minutes postinjection and static images are obtained for up to 3 hours postinjection.
Surgery is performed within 24 hours of lymphoscintigraphy. Patients are injected with patent blue V dye near the tumor and a gamma detection probe is used to measure radioactive counts in the sentinel node. Surgery begins within 5 minutes of the patent blue V dye injection.
All lymph nodes that stain blue or have a high radioactive count are removed. The primary breast lump is removed by either wide local excision or mastectomy and the axilla are cleared by standard axillary dissection.
Some patients may only receive patent blue V dye injected as a pilot study. Sentinel lymph node biopsy and axillary dissection proceed as above.
PROJECTED ACCRUAL: A total of 150 patients (75 per stratum) will be accrued for the main study plus another 50 patients for the pilot study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005821
|St. George's Hospital|
|London, England, United Kingdom, SW17 0QT|
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Royal Brompton National, Heart and Lung Hospital|
|London, England, United Kingdom, SW3 6NP|
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)||Royal Marsden NHS Foundation Trust|