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

Phase 2

Completed

Conditions: Invasive Breast Carcinoma
Ductal Breast Carcinoma In Situ
Progesterone Receptor Positive
Stage IA Breast Cancer
Estrogen Receptor Positive
Stage IB Breast Cancer
Stage IIA Breast Cancer

Interventions: Radiation: Accelerated Partial Breast Irradiation
Radiation: High-Dose Rate Brachytherapy
Other: Questionnaire Administration

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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment (APBI using HDR brachytherapy)	High-Dose Rate Brachytherapy	Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days.
Treatment (APBI using HDR brachytherapy)	Accelerated Partial Breast Irradiation	Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days.
Treatment (APBI using HDR brachytherapy)	Questionnaire Administration	Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days.

Primary Outcome Measures

Name	Time	Method
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	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Local Control Rate, Assessed by Physical Examination	3 years	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.
Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale	2 years	Descriptive statistics reported.
Local Control Rate, Assessed by Mammography	3 years	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.

Locations (10): 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
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
Arizona Breast Cancer
🇺🇸
Gilbert, Arizona, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States