Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
This phase II trial studies how well accelerated partial breast irradiation (APBI) using
 high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not
 spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation
 therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type
 of internal radiation therapy that provides radiation inside the breast to any remaining
 tumor cells next to the space where the tumor was removed, and is given over a shorter amount
 of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI)
 using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is
 delivered to the tumor cells.
PRIMARY OBJECTIVES:

 I. To determine the toxicity rate with shorter courses of accelerated partial breast
 irradiation (APBI) delivered with a breast brachytherapy applicator.

 SECONDARY OBJECTIVES:

 I. To determine the 3-year actuarial local control rate with abbreviated accelerated partial
 breast irradiation (APBI).

 II. To assess the rate of excellent or good cosmesis at 2-years after shorter courses of APBI
 and to identify co-variants associated with and predictive of poor cosmetic outcome in women
 treated with an overnight treatment course of APBI.

 OUTLINE:

 Within 1-5 days after balloon placement, patients undergo accelerated partial breast
 irradiation (APBI) using high-dose rate (HDR) brachytherapy over 15-60 minutes for 2-3 days.

 After completion of study treatment, patients are followed up at 2-8 weeks and then at least
 annually for 2 years.
Inclusion Criteria:

 -  Must sign informed consent

 -  Surgical treatment of the breast must have been lumpectomy; the margins of the
 resected specimen must be histologically free of tumor (negative surgical margins per
 National Surgical Adjuvant Breast and Bowel Project [NSABP] criteria)

 -  On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) and/or
 invasive breast carcinoma

 -  For patients with invasive breast cancer, an axillary staging procedure must be
 performed (either sentinel node biopsy [SNB] alone or axillary dissection [with a
 minimum of six axillary nodes removed], and the axillary node[s] must be
 pathologically negative); patients over 70 with estrogen receptor positive (ER+)
 tumors no greater than 2 cm do not require axillary evaluation, but MUST be clinically
 node negative on examination and all available imaging (clinical N0)

 -  The T stage must be Tis, T1, or T2; if T2, the tumor must be =< 3.0 cm in maximum
 diameter

 -  Estrogen receptor positive tumor and/or progesterone receptor positive tumor

 Exclusion Criteria:

 -  Pregnant or breast-feeding

 -  Active collagen-vascular disease

 -  Paget's disease of the breast

 -  Prior history of DCIS or invasive breast cancer

 -  Prior breast or thoracic radiation therapy (RT) for any condition

 -  Multicentric carcinoma (DCIS or invasive)

 -  Synchronous bilateral invasive or non-invasive breast cancer

 -  Surgical margins that cannot be microscopically assessed or that are positive

 -  Positive axillary node(s)

 -  T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage >= 3

 -  Estrogen receptor negative and progesterone receptor negative tumor

 -  Any of the dosimetric treatment criteria as defined have not been met; patients who
 become ineligible due to inability to meet dosimetric criteria should not receive
 treatment as defined in this protocol and will come off the study; any subsequent
 adjuvant radiation will be delivered at the discretion of the treating physician