Patient case: 45-year-old female with Melanoma. Genetic variant: BRAF (V600E), CDKN2A Deletion. Other conditions: None.

Clinical trial: Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases

Summary: RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.
  PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

Detailed description: OBJECTIVES:
  -  Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.
  -  Compare overall survival of patients treated with these regimens.
  -  Assess sites of recurrence, particularly reappearance of disease in the undissected axilla.
  -  Assess long-term surgical complications in patients treated with these regimens.
  OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Eligibility: DISEASE CHARACTERISTICS:
  -  Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
  -  Largest tumor lesion ≤ 5 cm
  -  Palpable or nonpalpable breast lesion
  -  Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions
  -  Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
  -  At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension
  -  No clinical evidence of distant metastases
  -  No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:
  -  Skeletal pain of unknown cause
  -  Elevated alkaline phosphatase
  -  Bone scan showing hot spots
  -  No palpable axillary lymph node(s)
  -  No Paget's disease without invasive cancer
  -  Hormone receptor status:
  -  Estrogen receptor and progesterone receptor known
  PATIENT CHARACTERISTICS:
  Age
  -  Any age
  Sex
  -  Female
  Menopausal status
  -  Any status
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  See Disease Characteristics
  Renal
  -  Not specified
  Other
  -  Not pregnant or nursing
  -  No other prior or concurrent malignancy except the following:
  -  Adequately treated basal cell or squamous cell skin cancer
  -  Adequately treated carcinoma in situ of the cervix
  -  Adequately treated in situ melanoma
  -  Contralateral or ipsilateral carcinoma in situ of the breast
  -  No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
  -  Geographically accessible for follow-up
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  See Disease Characteristics
  Other
  -  No prior systemic therapy for breast cancer
  -  More than 1 year since prior chemopreventive agent

Relevance to patient case: not relevant