Completed • Phase II • Stage 0, I, II • ER positive • PR positive • Post-Menopausal • Brain Metastases absent • Interventional

The following is imported from ClinicalTrials.gov:

Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery

Brief Summary

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.

Description

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.

Study Design

Eligibility Criteria

Arms and Intervention

• Accelerated Partial Breast Irradiation

• High-Dose Rate Brachytherapy

• Questionnaire Administration

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