NCT02526498

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
RADIATION	Accelerated Partial Breast Irradiation	Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy
RADIATION	High-Dose Rate Brachytherapy	Undergo APBI using HDR brachytherapy
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-07-15
• Primary completion: 2017-08-18
• Completion: 2021-03-31
• First posted: 2015-08-18
• Last updated: 2023-05-15
• Results posted: 2022-08-16

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study