Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer

Eligibility Criteria

• * Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.
• * Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.
• * Pregnancy test negative in women of child bearing potential (WOCBP).
• * The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
• * Participants 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. Participants 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.
• * Suitable:
• * Age: \>=50 years
• * Margins: Negative by at least 2 mm
• * T Stage: Tis or T1
• * Cautionary:
• * Age: 40-49 years
• * Margins: Negative by at least 2 mm
• * T Stage: Tis or T1 OR
• * Age: \>=50 years IF participant has at least 1 of the pathologic factors below and does not have any "unsuitable" factors (below)
• * Pathologic Factors:
• * Size 2.1-3.0 cm (size of the invasive component)
• * T2
• * Close margins (\<2 mm)
• * Limited/focal Lymphovascular Space Invasion (LVSI)
• * ER (-)
• * Clinically unifocal with total size 2.1-3.0 cm (Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm).
• * Invasive lobular histology
• * Extensive Intraductal Component (EIC) \<=3 cm
• * Suitable Criteria, DCIS allowed if all of the following are met:
• * Screen-detected
• * Low to intermediate nuclear grade
• * Size \<=2.5 cm
• * Resected with margins negative at \>=3mm OR
• * Cautionary Criteria:
• * Pure DCIS \<=3 cm if "suitable" criteria not fully met
• * Men are not eligible for this study.
• * 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 \>30mm (ASTRO Unsuitable Criteria).
• * Paget's disease of the nipple.
• * History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Participants with a history of 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 participant from meeting the study requirements.