4d image-guided partial breast radiation in stage 0 and l breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique.

this is a pilot study enrolling about 30 patients to evaluate the feasibility of using 4d ct and daily image guidance in accelerated partial breast irradiation (apbi) to decrease set-up error and individualized planning target volumes to limit the non-target breast tissue dose. the two specific breasts constraints which shall be decreased are the v50 (percent volume of breast receiving 50% of the prescribed dose) and the v100 (percent volume of breast receiving 100% of the prescribed dose). the goal will be to decrease these to 45% and 23.5% respectively, which is down 33% from the nsabp b39 standard of 60% and 35%.

Eligibility criteria:
inclusion criteria: * the patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines. * patient must be \> 50 years old. * the patient should have a life expectancy of at least two years with a karnofsky performance status \> 70. * the patient must have stage 0 or i breast cancer. * 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 (\>2mm, dcis and invasive). re-excision of surgical margins is permitted. * gross disease must be unifocal with pathologic (invasive and/or dcis) tumor size 2 cm or less. (patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.) * patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). axillary staging is not required for patients with dcis. * the patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure). * patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. * chemotherapy is permitted if planned for ≥ 2 weeks after radiation. * urine pregnancy test must be performed and be negative on all women younger than 60 who have not had a tubal ligation, oophorectomy, or hysterectomy. * separate incisions for the lumpectomy and sentinel node biopsy should be present. use of only one incision will typically result in a contiguous cavity with the tumor bed and the sentinel node sampling, and inability of the radiation oncologist to delineate the tumor bed from the sentinel node bed. * the patient must have a cavity which is able to be targeted with external beam apbi, either through surgical clip placement, or cvs 3 or higher. the cavity to whole breast ratio must be 30% or less. exclusion criteria: * men are not eligible for this study as men are not breast conservation candidates. * t0, t2 (\> 2.0 cm), t3, node positive, stage iii or iv breast cancer. * any positive axillary nodes. * palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor. * suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign. * non-epithelial breast malignancies such as sarcoma or lymphoma. * proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters. * paget's disease of the nipple. * history of invasive breast cancer or dcis in the same breast. * surgical margins that cannot be microscopically assessed or are less then 2 mm. * collagen vascular disease, specifically dermatomyositis with a cpk level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma. * pregnancy or lactation at the time of proposed radiation. 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 treating physician, would preclude the patient from meeting the study requirements. * patients with coexisting medical conditions in whom life expectancy is \< 2 years. * patients with skin involvement, regardless of tumor size.

Keywords: breast cancer radiation for breast cancer