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

Invasive Breast Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02526498
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact
Status Completed
Phase Phase 2
Start date July 15, 2015
Completion date March 31, 2021
View Details
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