Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
Brief 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.


Options:
A: 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
B: DISEASE CHARACTERISTICS:

* Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer

  * T0-2, N0
  * Diagnosis by excisional tumorectomy allowed
  * Clinically occult invasive disease must be histologically confirmed
* Only 1 tumor in 1 breast

  * Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram, ultrasound or MRI

    * Multifocal (i.e., within one quadrant and sharing the same histological characteristics) is allowed
    * Multicentric (i.e., in different quadrants) breast cancer is not allowed
* Clinically negative axillary lymph nodes
* No metastatic disease
* No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic treatment
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Any age

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to axilla

Surgery:

* No prior surgery to axilla

Other:

* See Disease Characteristics
C: 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
D: Inclusion criteria:

Women, 50 year or more Menopausal women Breast cancer Macroscopic tumor size of 10 mm or less (measured during operation) No palpable axillary node ( N0)

Exclusion criteria:

Previous cancer history life expectancy \< 10 years Metastasis

Answer: A