MRI-Guided Accelerated Partial Breast Irradiation in Treating Patients with Early Breast Cancer

Inclusion Criteria

• Patients should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.
• Lumpectomy cavity must be clearly visible on computed tomography (CT) and MRI scan at radiotherapy simulation.
• Pregnancy test negative in women of child bearing potential (WOCBP).
• The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
• Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
• Patient must be female
• Treating physician must confirm patient eligibility with the study coordinator using American Society for Radiation Oncology (ASTRO) guideline table

Exclusion Criteria

• BRCA1/2 mutation positivity.
• Age < 40 years (American Society for Radiation Oncology [ASTRO] unsuitable criteria).
• Positive resection margins on post operative pathology (ASTRO unsuitable criteria).
• Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
• Suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
• Non-epithelial breast malignancies such as sarcoma or lymphoma.
• Proven multicentric carcinoma (invasive cancer or DCIS) (ASTRO unsuitable criteria).
• Pure DCIS > 3 cm in size (ASTRO unsuitable criteria).
• Presence of extensive intraductal component > 30 mm (ASTRO unsuitable criteria).
• Presence of extensive lympho-vascular space invasion. (ASTRO unsuitable criteria).
• Paget's disease of the nipple.
• History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Patients with a history of lobular breast carcinoma in situ [LCIS] treated by surgery alone are eligible.)
• Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
• Concurrent therapy with any hormonal agents such as raloxifene (Evista), tamoxifen, aromatase inhibitors or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention or neoadjuvant therapy.
• Breast implants.
• Prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation.
• Collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
• Pregnancy or lactation at the time of treatment. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.