Please select the eligibility criteria that correspond to the clinical trial below.
Title: QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS
Brief Summary: RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.


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 proven stage I, invasive breast cancer
* Hormone receptor status:

  * Estrogen receptor positive
  * Progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

Age:

* 65 to 80

Sex:

* Female

Menopausal status:

* Postmenopausal

Performance status:

* Not specified

Life Expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No serious disease that would preclude surgery
* No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

* Not specified
C: 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
D: 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

Answer: B