Radiation Therapy in Treating Women With Localized Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.

Detailed Description
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OBJECTIVES: Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic breast appearance, in women with localized breast cancer who are at average or low risk of recurrence. Compare tumor control in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms. Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks. Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks. Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once a week for 5 weeks. After completion of study treatment, patients are followed annually for 5-10 years. PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this study within 12 months.

Official Title
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Prospective Randomised Clinical Trial Testing 5.7 Gy and 6.0 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of invasive carcinoma of the breast Localized disease Pathological tumor size < 3.0 cm in diameter Axillary node negative At average or low risk of local tumor recurrence Must have undergone prior breast-preserving surgery No prior mastectomy Complete microscopic resection of tumor Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 50 and over Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior neoadjuvant or adjuvant cytotoxic chemotherapy Endocrine therapy Not specified Radiotherapy No concurrent lymphatic radiotherapy No concurrent radiotherapy boost to the breast Surgery See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 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: Control<br>50Gy in 25 fractions of radiation therapy over 5 weeks | Radiation: Radiation therapy<br> <br> |
| Active Comparator: Test group 1<br>30Gy in 5 fractions of radiation therapy over 5 weeks | Radiation: Radiation therapy<br> <br> |
| Active Comparator: Test group 2<br>28.5Gy in 5 fractions of radiation therapy over 5 weeks | Radiation: Radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in photographic breast appearance | Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph | 2 years post randomisation | 

 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