Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: conventional surgery; Sentinel node resection followed by node examination
Intervention description: Sentinel node resection immediately followed by axillary dissection.; Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5611.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I breast cancer; stage II breast cancer

Summary:

      RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help
      plan more effective surgery for breast cancer. It is not yet known if surgery to remove the
      sentinel lymph nodes is more effective with or without removal of the lymph nodes in the
      armpit in treating breast cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the
      sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women
      who have breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following:

               -  Histologically confirmed by core or open biopsy

               -  Confirmed by fine needle aspiration cytology AND positive clinical breast
                  examination and ultrasound or mammography

          -  Clinically negative lymph nodes

               -  No positive ipsilateral axillary lymph nodes

               -  No prior removal of ipsilateral axillary lymph nodes

               -  No suspicious palpable nodes in the contralateral axilla or palpable
                  supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy

          -  No ulceration, erythema, infiltration of the skin or underlying chest wall (complete
             fixation), peau d'orange, or skin edema of any magnitude

               -  Tethering or dimpling of the skin or nipple inversion allowed

          -  No bilateral malignancy or mass in the opposite breast that is suspicious for
             malignancy, unless proven nonmalignant by biopsy

          -  No diffuse tumors or multiple malignant tumors in different quadrants of the breast

          -  No other prior breast malignancy except lobular carcinoma in situ

          -  No prior or concurrent breast implants

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age:

          -  18 years and older

        Sex:

          -  Female

        Menopausal status:

          -  Not specified

        Performance status:

          -  Not specified

        Life expectancy:

          -  At least 10 years (excluding diagnosis of cancer)

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  No hepatic systemic disease

        Renal:

          -  No renal systemic disease

        Cardiovascular:

          -  No cardiovascular systemic disease

        Other:

          -  No prior malignancy within past 5 years except:

               -  Effectively treated squamous cell or basal cell skin cancer

               -  Surgically treated carcinoma in situ of the cervix

               -  Surgically treated lobular carcinoma in situ of the ipsilateral or contralateral
                  breast

          -  No concurrent psychiatric or addictive disorder

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy for this cancer

        Chemotherapy:

          -  No prior chemotherapy for this cancer, including neoadjuvant chemotherapy

        Endocrine therapy:

          -  No prior hormonal therapy for this cancer

        Radiotherapy:

          -  No prior radiotherapy for this cancer

        Surgery:

          -  See Disease Characteristics

          -  No prior breast reduction surgery

          -  Prior excisional biopsy or lumpectomy allowed