Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing Axillary Dissection "by Principle" and Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma of Small Size
Brief Summary: The purpose of this study is to evaluate the disease free and overall survival of patients with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non palpable axillary lymph nodes, undergoing either conservative surgery and axillary dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel lymph node, the result of which determines axillary node dissection or its avoidance is based.


Options:
A: Inclusion Criteria:

* Age between 40 and 75 years.
* Clinical, mammographic or ultrasonographic diagnosis of a unicentric carcinoma with an ultrasonographic diameter of equal or less than 2.0 cm.
* Although not a factor of exclusion, a breast scintigraphy using MDP-99m is recommended for accurate determination of possible multifocality or multicentricity of the tumor, as well as for the determination of possible bone metastasis.
* Axillary lymph nodes that cannot be palpated or that are not clinically suspicious for metastasis.
* No previously executed therapy (including biopsy) at any outside institution.
* Those patients with nonpalpable lesions will be subjected to preoperative radioactive occult lesion localization (ROLL) or stereotactic biopsy.
* Adequate patient information and signature of the informed consent.

Exclusion Criteria:

* Lesions diagnosed as non-infiltrating (in-situ) ductal or lobular carcinoma.
* Paget's disease.
* Documented multicentricity and/or abundant multifocality of the neoplasm.
* Clinically metastatic lymph nodes.
* Patients previously biopsied at other institutions.
* Carcinomas detected during pregnancy or lactation.
* Histotypes diverse from breast carcinoma lesions.
* History of previous malignancy (excluding basocellular carcinoma, in-situ cervical carcinoma and/or contralateral breast carcinoma without recurrence for at least 15 years of follow-up).
B: 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
C: 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
D: 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

Answer: A