|No phase specified||Treatment||Closed||18 and over||NCI, Other||CASE2104|
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.
Further Study Information
- 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.
- 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
- 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
Trial Lead Organizations/Sponsors
Case Comprehensive Cancer CenterNational Cancer Institute
|Janice Lyons, MD||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00527293
ClinicalTrials.gov processed this data on October 17, 2013
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