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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy
Undergo APBI using HDR brachytherapy
Ancillary studies
Arizona Breast Cancer
Gilbert, Arizona, United States
University of California, San Diego
La Jolla, California, United States
William Beaumont Hospital Research Institute
Royal Oak, Michigan, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
21st Centry Oncolgy
Yonkers, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Huntsman Cancer Hospital, University of Utah
Salt Lake City, Utah, United States
Number of Participants With Adverse Events Greater Than Grade 2 Serious Toxicity Rate, Defined as Toxicity Greater Than Grade 2 Using Common Terminology Criteria for Adverse Events Version 4.0 Criteria
Measured by the data collected for toxicity and cosmesis as dichotomous variables. This will be assessed by physical examination at each follow-up visit. To be scored as a serious toxicity counting toward the primary endpoint, the toxicity must have a "probable" or "definite" attribution to the study treatment.
Time frame: 2 years
Local Control Rate, Assessed by Physical Examination
The association of variables with local regional failure times will be investigated by fitting a parametric model and examining the significance of the parameter estimates. Nonparametric estimates of the survival or recurrence-free distributions or recurrence (failure) distribution will be obtained by life table methods.
Time frame: 3 years
Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale
Descriptive statistics reported.
Time frame: 2 years
Local Control Rate, Assessed by Mammography
Assessed using the Kaplan-Meier method. The association of variables with local regional failure times will be investigated by fitting a parametric model and examining the significance of the parameter estimates. Nonparametric estimates of the survival or recurrence-free distributions or recurrence (failure) distribution will be obtained by life table methods. Tests will be declared statistically significant if the calculated P-value was =\< 0.05. All tests appear as 2-sided P-values.
Time frame: 3 years
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