Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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After Mapping Of The Axilla: Radiotherapy Or Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: axillary lymph node dissection
* Procedure: lymphoscintigraphy
* Procedure: therapeutic conventional surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: axillary lymph node dissection<br>complete axillary lymph node dissection | Procedure: axillary lymph node dissection<br> <br> Procedure: lymphoscintigraphy<br> <br> Procedure: therapeutic conventional surgery<br> <br> |
| Experimental: axillary radiotherapy<br>axillary radiotherapy, daily for 5 days a week, for 5 weeks | Procedure: lymphoscintigraphy<br> <br> Procedure: therapeutic conventional surgery<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary recurrence rate |  | from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery |  | from randomization | 
| Quality of life as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR25 at baseline, 1, 2, 3, and 5 years after surgery |  | from randomization | 
| Axillary recurrence-free survival |  | from randomization | 
| Disease-free survival |  | from randomization | 
| Overall survival |  | from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IA breast cancer, stage IB breast cancer, stage II breast cancer