Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer (NCT01245712) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
United States200 participantsStarted 2010-11-15
Plain-language summary
This phase II trial studies the side effects and how well radiation therapy works in treating patients with stage 0-II breast cancer. Specialized 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
✓. Patients must be \>/= 18 years old. (Adenocarcinoma of the breast is not seen in children)
✓. English and non-English speaking patient
✓. The patient must have stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
✓. On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
✓. Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive).
✓. Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)
✓. Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS.
Exclusion criteria
✕. Men are not eligible for this study.
✕. Individuals that are considered to be cognitively impaired.
✕. T2 (\> 3.0 cm), T3, stage III, or stage IV breast cancer.
✕. More than 3 histologically positive axillary nodes.
✕. Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
✕. Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment unless there is histologic confirmation that these nodes are negative for tumor.
✕. Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign.
✕. Non-epithelial breast malignancies such as sarcoma or lymphoma.