Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal. PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer.

Detailed Description
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OBJECTIVES: Compare local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection. Compare the toxicity of these regimens in these patients. Compare the quality of life in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center. Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo sentinel node biopsy. Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence in the conserved breast, patients undergo total mastectomy; those in arm II who experience ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up are continued. Quality of life is assessed. Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within approximately 5 years.

Official Title
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Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: tamoxifen citrate
* Procedure: conventional surgery
* Radiation: radiation therapy
* Procedure: Axillary clearance


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable No prior axillary clearance or biopsy Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy) Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 60 and over Sex: Female Menopausal status Postmenopausal Performance status: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 1.1 mg/dL AST less than 60 U/L Renal: Creatinine less than 1.3 mg/dL Cardiovascular: Normal cardiac function No history of congestive heart failure Other: No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up No psychiatric or addictive disorder that would preclude protocol therapy or informed consent No other prior or concurrent malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix Geographically accessible for follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for breast cancer Chemotherapy: No prior chemotherapy for breast cancer Endocrine therapy: No prior endocrine therapy for breast cancer Radiotherapy: No prior radiotherapy for breast cancer Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 60 Years

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 |
| --- | --- |
| Experimental: Surgery w/ axillary clearance, tamox<br>Either a total mastectomy with axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse. | Drug: tamoxifen citrate<br>* 20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.<br>Procedure: conventional surgery<br>* Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).<br>Radiation: radiation therapy<br>* No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.<br>Procedure: Axillary clearance<br>* Axillary node dissection.<br>|
| Experimental: Surgery w/o axillary clearance, tamox<br>Either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse. | Drug: tamoxifen citrate<br>* 20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.<br>Procedure: conventional surgery<br>* Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).<br>Radiation: radiation therapy<br>* No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first. | 17 years from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from randomization to death. | 17 years from randomization | 
| Toxicity | Side effects of treatment, especially surgery-related events. | 17 years from randomization | 
| Quality of life | Quality of life will be assessed by standard International Breast Cancer Study Group instruments | 17 years from randomization | 

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