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.

Condition	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer	Drug: patent blue V dye  Drug: technetium Tc 99m human serum albumin colloid  Procedure: conventional surgery  Procedure: diagnostic test  Procedure: lymphography  Procedure: radionuclide imaging  Procedure: sentinel node biopsy  Procedure: surgery	Phase II

Further Study Details: 

OBJECTIVES:

• Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in patients 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of stage I or II invasive breast cancer by triple assessment:
• Clinically
• Mammogram and/or ultrasound
• Fine needle cytology
• Resectable disease by either wide local excision or mastectomy with axillary dissection
• No ductal carcinoma in situ
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant
• No known allergy to vital blue dye
• No mental illness or handicap that would preclude study entry
• No other severe illness that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

United Kingdom, England
      Royal Brompton National, Heart and Lung Hospital, London,  England,  SW3 6NP,  United Kingdom
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom
      Royal Marsden NHS Trust, London,  England,  SW3 6JJ,  United Kingdom
      St. George's Hospital, London,  England,  SW17 0QT,  United Kingdom

Study chairs or principal investigators

Gerald Gui, MD, MS, F.R.C.S.(Edin),  Study Chair,  Royal Marsden NHS Trust   

Study ID Numbers:  CDR0000067828; RMNHS-1631; EU-20006
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005821
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08