Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less
 invasive treatment and cause fewer side effects than complete axillary lymph node dissection.
 It is not yet known which treatment is more effective for invasive breast cancer.

 PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph
 node dissection with that of axillary radiation therapy in treating women who have invasive
 breast cancer.
OBJECTIVES:

 -  Compare the regional control of the axilla obtained by complete axillary lymph node
 dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable
 invasive breast cancer.

 -  Determine whether local and regional axillary control can be obtained without axillary
 lymph node dissection in sentinel lymph node-negative women.

 -  Compare the axillary 5-year recurrence-free survival of these patients treated with
 these regimens.

 -  Compare the morbidity of patients treated with these regimens.

 -  Compare the quality of life of these patients treated with these regimens.

 OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
 participating center and type of breast surgery (conservation vs total mastectomy). Patients
 are randomized to 1 of 2 treatment arms.

 Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to
 identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo
 wide local excision of the tumor or mastectomy after the sentinel node is removed. If no
 sentinel node is found or metastasis is found in a nonsentinel node, patients undergo
 complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel
 node-negative patients receive no further treatment. Sentinel node-positive patients continue
 treatment according to randomization.

 -  Arm I: Within 8 weeks after surgery, patients undergo complete ALND.

 -  Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy
 daily 5 days a week for 5 weeks.

 Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are
 positive and more than 1 axillary level is involved.

 Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.

 Patients are followed annually for 5 years.

 PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091 sentinel
 node-negative) will be accrued for this study within 3 years.
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