Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer

Phase 2

• Conditions: Breast Cancer

• Registration Number: NCT00005821
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Study Timeline

• Study Start: 1998-12
• Study First Submitted: 2000-06-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2003-03
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Royal Marsden NHS Trust; 🇬🇧 London, England, United Kingdom

Royal Marsden Hospital; 🇬🇧 Sutton, England, United Kingdom

St. George's Hospital; 🇬🇧 London, England, United Kingdom

Royal Brompton National, Heart and Lung Hospital; 🇬🇧 London, England, United Kingdom