Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer
Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer
RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph
 nodes, may improve the ability to detect the extent of disease and help plan effective
 surgery for removing breast tumors.

 PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to
 identify the sentinel lymph node under the arm in women with stage I or stage II breast
 cancer.
OBJECTIVES: I. Determine whether the concept of a sentinel lymph node within the axillary
 nodal basin is valid in staging breast cancer. II. Determine the sensitivity of combined
 methods of identification of sentinel lymph nodes by patent blue V dye and gamma probe
 detection in these women.

 OUTLINE: Patients receive patent blue V dye injection peritumorally prior to surgery.
 Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid
 injected around the tumor associated with intraoperative gamma probe detection. Nonpalpable
 tumors receive a localized injection using stereotactic injection techniques. Patients then
 undergo standard axillary (level I and II) lymph node dissection.

 PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 1 year.
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I or IIA invasive
 breast cancer T0, T1, or T2 (no greater than 3 cm), N0 Noninflammatory Nonmetastatic No
 ductal carcinoma in situ Eligible for breast-conserving surgery Hormone receptor status:
 Positive or negative

 PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Pre- and
 postmenopausal Performance status: Not specified Life expectancy: Not specified
 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not
 pregnant No allergy or sensitivity to radiopharmaceuticals or patent blue V dye

 PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
 prior neoadjuvant chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy:
 No prior neoadjuvant radiotherapy Surgery: No prior breast surgical biopsy or axillary
 surgery