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 kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer.

Detailed Description
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OBJECTIVES: Primary Compare the ratio between post- and pre-treatment plasma transforming growth factor-beta 1 (TGF-β) in women with invasive breast cancer undergoing hypofractionated radiotherapy vs standard-fractionated external-beam radiotherapy. Secondary Establish longitudinal serum and plasma biorepository for retrospective evaluation of TGF-β and other biomarkers with special relevance to radiation response. Correlate pre-treatment plasma TGF-β levels with clinical fibrosis development. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I (hypofractionated radiotherapy): Patients undergo external-beam radiotherapy once daily 5 days a week for up to 3.5 weeks (16 fractions total). Arm II (standard fractionated radiotherapy): Patients undergo radiotherapy as in arm I at a lower dose for up to 5 weeks (25 fractions total). After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Official Title
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The Relationship Between Plasma Transforming Growth Factor-beta 1 (TGF-β) and Fractionation in Radiotherapy for Breast Cancer: A Randomized Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed invasive breast cancer Underwent lumpectomy (breast-preserving surgery) with or without adjuvant chemotherapy within the past 12 weeks Histologically negative surgical margins (i.e., no tumor on ink) Candidates for postoperative breast radiotherapy Determined not to need radiotherapy to regional nodes (e.g., third supraclavicular field) Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of scleroderma or systemic lupus erythematosis No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior breast radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Procedure: adjuvant therapy|nan|
|Radiation: radiation therapy|nan|

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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invasive ductal breast carcinoma, invasive lobular breast carcinoma, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer