S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II 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. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.

Detailed Description
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OBJECTIVES: Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy and/or hormonal therapy. Compare local regional control in patients treated with these regimens. Assess the potential toxic effects of radiotherapy in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two treatment arms. Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks. Arm II: Patients are observed for disease progression. Patients are followed every 6 months for 2 years and then annually for 15 years. PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for this study within 5 years.

Official Title
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Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: radiation therapy
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0) Primary tumor no greater than 5 cm At least 1 but no more than 3 positive axillary lymph nodes Nodes cannot be positive solely by cytokeratin staining No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast No bilateral breast cancer No active local regional disease Must have undergone a modified radical mastectomy with a level I and II with or without a level III axillary dissection (at least 10 nodes examined) within the past 8 months Surgical margins negative for invasive and noninvasive ductal carcinoma No gross extracapsular disease or residual disease in the axilla Microscopic extracapsular extension allowed No mastectomy after local failure following lumpectomy Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 21 and over Sex: Female Menopausal status: Pre- or post-menopausal Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No serious medical or psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No prior trastuzumab (Herceptin) Chemotherapy: See Disease Characteristics No more than 6 weeks since prior adjuvant chemotherapy No other prior chemotherapy Concurrent adjuvant chemotherapy allowed Endocrine therapy: See Disease Characteristics Concurrent adjuvant hormonal therapy allowed Radiotherapy: No prior chest wall or nodal radiotherapy Surgery: See Disease Characteristics Breast reconstruction allowed Other: Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is allowed

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| Active Comparator: surgery<br>surgery followed by observation | Procedure: surgery<br>* surgery<br>|
| Experimental: surgery followed by RT<br>Surgery followed by radiation therapy | Radiation: radiation therapy<br> <br> Procedure: surgery<br>* surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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