Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
This phase II trial studies the side effects and how well radiation therapy works in treating
 patients with stage 0-II breast cancer. Specialized radiation therapy that delivers a high
 dose of radiation directly to the tumor may kill more tumor cells and cause less damage to
 normal tissue.
PRIMARY OBJECTIVES:

 I. To assess the cosmesis, acute toxicity and late toxicity in patients treated with
 accelerated partial breast irradiation delivered with proton radiation.

 SECONDARY OBJECTIVES:

 I. To evaluate the convenience of accelerated partial breast irradiation and quality of life
 during accelerated partial breast irradiation.

 II. To estimate the in-breast tumor control rates in patients treated with accelerated
 partial breast irradiation delivered with proton radiation.

 III. Compare dosimetry to alternate treatment modalities.

 OUTLINE:

 Within 10 weeks of last breast cancer surgery, patients undergo accelerated partial breast
 irradiation (APBI) delivered with proton radiation twice daily (BID) for 5 days.

 After completion of study treatment, patients are followed up at 6 weeks, 6 months, 1 year,
 and 18 months, then annually for 10 years.
Inclusion Criteria:

 -  The patient must consent to be in the study and must have signed an approved consent
 form conforming with federal and institutional guidelines

 -  The patient must have stage 0, I, or II breast cancer; if stage II, the tumor size
 must be 3 cm or less

 -  On histological examination, the tumor must be ductal carcinoma in situ (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 (DCIS and invasive); reexcision
 of surgical margins is permitted

 -  Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm
 or less; (patients with microscopic multifocality are eligible as long as total
 pathologic tumor size is 3 cm or less)

 -  Patients with invasive breast cancer are required to have axillary staging which can
 include sentinel node biopsy alone (if sentinel node is negative), sentinel node
 biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary
 nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of
 6 axillary nodes); axillary staging is not required for patients with DCIS

 -  The target lumpectomy cavity must be clearly delineated and the target lumpectomy
 cavity/whole breast reference volume must be less than or equal to 30% based on the
 postoperative/pre-enrollment computed tomography (CT) scan

 -  Patients are eligible if, based on the postoperative CT scan, partial breast
 irradiation (PBI) is judged to be technically deliverable

 -  Patients with a history of non-breast malignancies are eligible if they have been
 disease-free for 5 or more years prior to enrollment and are deemed by their physician
 to be at low risk for recurrence; patients 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

 Exclusion Criteria:

 -  Men are not eligible for this study

 -  T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer

 -  More than 3 histologically positive axillary nodes

 -  Axillary nodes with definite evidence of microscopic or macroscopic extracapsular
 extension

 -  Palpable or radiographically suspicious ipsilateral or contralateral axillary,
 supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment
 unless there is histologic confirmation that these nodes are negative for tumor

 -  Suspicious microcalcifications, or densities (in the ipsilateral or contralateral
 breast as documented on mammogram or breast ultrasound) unless biopsied and found to
 be benign

 -  Non-epithelial breast malignancies such as sarcoma or lymphoma

 -  Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or
 separated by 4 or more centimeters

 -  Paget's disease of the nipple

 -  Synchronous bilateral invasive or non-invasive breast cancer

 -  Surgical margins that cannot be microscopically assessed or are positive at pathologic
 evaluation; (if surgical margins are rendered free of disease by reexcision, the
 patient is eligible)

 -  Clear delineation of the extent of the target lumpectomy cavity not possible

 -  Treatment plan that includes regional nodal irradiation

 -  Prior radiation to the index breast

 -  Documented diagnosis of collagen vascular disease, specifically dermatomyositis with a
 creatinine phosphokinase (CPK) level above normal or with an active skin rash,
 systemic lupus erythematosus, or scleroderma

 -  Pregnancy or lactation at enrollment

 -  Women of reproductive potential must agree to use an effective non-hormonal method of
 contraception during therapy