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Brief Title: Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
Official Title: TRI-fraction Radiotherapy Utilized to Minimize Patient Hospital Trips : A Phase II Trial (TRIUMPH-T Trial)
Study ID: NCT02526498
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.
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, 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
Name: Bruce Haffty, MD
Affiliation: Rutgers Cancer Institute of New Jersey
Role: PRINCIPAL_INVESTIGATOR