Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.

Detailed Description
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OBJECTIVES: To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques. To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire. To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique. To evaluate wound healing and overall complication rate after partial breast irradiation. To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates. OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days. After completion of study therapy, patients are followed periodically for up to 5 years.

Official Title
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Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: adjuvant therapy
* Radiation: 3-dimensional conformal radiation therapy
* Radiation: brachytherapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer, including the following histologic subtypes: Invasive ductal carcinoma Medullary ductal carcinoma Papillary ductal carcinoma Colloid (mucinous) ductal carcinoma Tubular ductal carcinoma The following histologic subtypes are not allowed: Invasive lobular carcinoma Extensive lobular carcinoma in situ Ductal carcinoma in situ (DCIS) Nonepithelial breast malignancies, such as lymphoma or sarcoma No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue) Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a) Lesion ≤ 3 cm No more than 3 positive lymph nodes Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy) Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin Unifocal breast cancer No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm) No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative No skin involvement of disease No Paget's disease of the nipple No distant metastatic disease Hormone-receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified Not pregnant or lactating Negative pregnancy test Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent No other malignancy within the past 5 years, except non-melanomatous skin cancer PRIOR CONCURRENT THERAPY: No prior radiotherapy to the breast No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy Concurrent hormonal therapy allowed

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MammoSite Brachytherapy<br>Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days | Procedure: adjuvant therapy<br>* If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.<br>Radiation: brachytherapy<br>* Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days<br>|
| Experimental: 3-dimensional conformal radiotherapy<br>3-dimensional conformal radiotherapy twice daily for 5-10 days. | Procedure: adjuvant therapy<br>* If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.<br>Radiation: 3-dimensional conformal radiation therapy<br>* 3-dimensional conformal radiotherapy twice daily for 5-10 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon |  | 1 month after RT & Q3mos for one year | 
| Patient satisfaction with partial breast irradiation as measured by a questionnaire |  | Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr | 
| Wound healing and overall complication rate after partial breast irradiation |  | 1 month after RT & Q3mos for one year | 
| Determination of which patients are best suited for each individual technique of partial breast irradiation |  | Patients will be followed for a period of five years following completion of radiation. | 
| Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates |  | Ipsilateral breast 6 mos after dx, bilateral annually x 5 years | 

 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, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, tubular ductal breast carcinoma, papillary ductal breast carcinoma