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Protocol No. UW18099

Principal Investigator Anderson, Bethany

Phase II

Age Group Adult

Scope Local

Sponsor Type Institutional

Title A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)

Objective The purpose of this study is to develop a radiotherapy treatment schedule that will help treat the part of the breast where the tumor was removed and spare the remaining healthy breast tissue from high dose radiation

Treatment Prior to treatment patients will have a daily free-breathing MRI done, then patients will receive 3 sessions of focused breast radiotherapy delivered every other day, over a 5 to 6 day period

Description Phase II study of MRI guide Accelerated Partial breast radiation

Key Eligibility
SUITABLE:Invasive Cancer Suitable Eligibility Criteria age greater than or equal to 50 years: Negative margins by at least 2 mm, T stage Tis or T1, if patient has DCIS must meet the following critieria: DCIS screen-detected, low to intermediate grade, less than or equal to 2.5 cm, resected margins negative at greater than or equal to 3 mm OR
CAUTIONARY:Invasive Cancer Cautionary Eligibility Criteria age 40-49 years: Negative margins by at least 2 mm, stage Tis or T1, If the patient has DCIS must meet the following criteria: DCIS screen-detected, low to intermediate grade, DCIS size less than or equal 2.5 cm, resected margins negative at greater than or equal 3 mm OR
Invasive Cancer Cautionary Eligibility Criteria age greater than or equal to 50 years IF patient has AT LEAST 1 of the pathologic factors below and does not meet any ineligibility criteria: tumor size 2.1 to 3.0 cm, stage T2, Are the margins close (less than 2 mm), LVSI limited or focal, ER status negative, is the pathology clinically unifocal with a total size 2.1 -3.0 cm, histology considered invasive lobular, pure DCIS less than equal to 3 cm, EIC less than or equal to 3 cm
  • Must not have any contraindications to undergo MRI scan as part of radiotherapy planning and treatment
  • The lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation
  • Can not be pregnant or breastfeeding
  • Must be disease-free for 5 or more years if they have a history of non breast malignancies (carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situr, and basal cell and squamous cell carcinoma of the skin) and are deemed by the physician for low risk of recurrence
    EXCLUSION:
  • Can not have the BRCA ½ mutation positivity
  • Must be 40 years of age or older
  • The resection margins can not be positive on post operative pathology
  • No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes? (unless histologicially confirmed as negative for tumor)
  • No suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
  • Must not have non-epithelial breast malignancies such as sarcoma or lymphoma
  • Can not have cancer proven multicentric carcinoma (invasive cancer or DCIS)
  • No pure DCIS greater than 3cm
  • No presence of extensive intraductal components greater than 30 mm
  • No presence of extensive lympho-vascular space invasion
  • Can not have paget’s disease of the nipple
  • No history of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer(Patients with a history of LCIS treated by surgery alone are eligible) surgical margins must be microscopically assessed or are the margins positive at pathologic evaluation
  • Patient can not be on 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
  • No breast implants allowed
  • No prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation
  • No collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics