real-time mri-guided 3-fraction accelerated partial breast irradiation in early breast cancer

Conditions: Breast Cancer; DCIS; LCIS

Summary: this trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (bct) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) mri-guided radiotherapy (mridian) would limit the volume of normal tissue radiated and therefore resultant toxicity. the hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. participants can expect to be on study for follow up up to 5 years.


Eligibility criteria:
inclusion criteria: for all participants * 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. for participants with invasive carcinoma * 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 for participants with dcis * 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 exclusion criteria (unsuitable criteria) : * 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.

Keywords: cosmesis cosmetic breast-conserving therapy