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

Study Overview
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Brief Summary
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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
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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.

Official Title
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TRI-fraction Radiotherapy Utilized to Minimize Patient Hospital Trips : A Phase II Trial (TRIUMPH-T Trial)

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

Intervention / Treatment
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* Radiation: Accelerated Partial Breast Irradiation
* Radiation: High-Dose Rate Brachytherapy
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (APBI using HDR brachytherapy)<br>Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. | Radiation: Accelerated Partial Breast Irradiation<br>* Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy<br>* Other names: APBI;Radiation: High-Dose Rate Brachytherapy<br>* Undergo APBI using HDR brachytherapy<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years | 
| Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale | Descriptive statistics reported. | 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. | 3 years |