Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early 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. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which radiation therapy schedule is more effective in treating breast cancer. PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.

Detailed Description
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OBJECTIVES: To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence. OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms. Arm I (control): Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy). Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy). Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy). Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor. After completion of study treatment, patients are followed annually for 10 years.

Official Title
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Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: intensity-modulated radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed invasive breast cancer Resectable, unilateral disease T1-3, N0-1, M0 disease Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following: Age 18-49 years Tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component) Tumor of any size treated by primary medical therapy Grade III disease Minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia) Lymphovascular invasion Axillary node positive Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior mastectomy No concurrent chemotherapy except primary or sequential chemotherapy

Ages Eligible for Study
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Minimum Age: 18 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (control)<br>Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy). | Radiation: intensity-modulated radiation therapy<br>* Given as 48, 53, or 56 Gy<br>|
| Experimental: Arm II<br>Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy). | Radiation: intensity-modulated radiation therapy<br>* Given as 48, 53, or 56 Gy<br>|
| Experimental: Arm III<br>Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy). | Radiation: intensity-modulated radiation therapy<br>* Given as 48, 53, or 56 Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palpable induration inside the boost volume of the irradiated breast |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires) |  |  | 
| Local tumor control |  |  | 
| Location of tumor relapse in breast |  |  | 
| Contralateral primary tumors |  |  | 
| Regional and distant metastases |  |  | 
| Overall survival |  |  | 

 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, stage IIIA breast cancer