4D Image-Guided Partial Breast Radiation in Stage 0 and l Breast Cancer
4D Image-Guided Partial Breast Radiation in Stage 0 and l Breast Cancer
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%.
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.