RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.

Condition	Treatment or Intervention
stage I breast cancer stage II breast cancer	Drug: patent blue V dye  Drug: technetium Tc 99m sulfur colloid  Procedure: diagnostic test  Procedure: radionuclide imaging  Procedure: sentinel node biopsy

Further Study Details: 

OBJECTIVES:

• Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification.
• Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs.
• Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid.
• Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection.

Patients are followed for disease evolution.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed invasive breast cancer
• T0, T1, or T2 no greater than 3 cm, N0
• Amenable to surgery
• No inflammatory breast cancer
• No ductal cancer in situ or multicentric invasive ductal cancer
• No nipple/areola or central breast cancer (at least 2 cm from areola)
• No metastatic disease
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age

• Over 18

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant
• Negative pregnancy test
• No known allergy or intolerance to patent blue V dye

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• No prior surgery for cancer

Other

• No prior neoadjuvant treatment for cancer

France
      Centre Jean Perrin, Clermont-Ferrand,  63011,  France
      Centre Leon Berard, Lyon,  69373,  France
      Centre Paul Strauss, Strasbourg,  67085,  France
      Centre Regional Rene Gauducheau, Nantes-Saint Herblain,  44805,  France
      Clinique Tivoli, Bordeaux,  F-33030,  France
      Institut Claudius Regaud, Strasbourg,  67085,  France
      Institut J. Paoli and I. Calmettes, Marseille,  13273,  France

Study chairs or principal investigators

Jean-Francois Rodier, MD,  Study Chair,  Centre Paul Strauss   

Study ID Numbers:  CDR0000258612; STRAUSS-FRANSENOD; EU-20214
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052676
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08