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

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

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.

Study Overview

• Status: Completed
• Conditions: Invasive Breast Carcinoma; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Estrogen Receptor Positive; Progesterone Receptor Positive; Ductal Breast Carcinoma In Situ
• Intervention / Treatment: Other: Questionnaire Administration; Radiation: Accelerated Partial Breast Irradiation; Radiation: High-Dose Rate Brachytherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Arizona Breast Cancer
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital Research Institute
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • RWJBarnabas Health - Robert Wood Johnson University Hospital
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Yonkers, New York, United States, 10457
      • 21st Centry Oncolgy
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Hospital, University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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 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
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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Rutgers Cancer Institute of New Jersey; Elekta Limited; Cianna Medical, Inc.
• Investigators: Principal Investigator: Bruce Haffty, MD, Rutgers Cancer Institute of New Jersey

Publications and helpful links

General Publications

• Khan AJ, Chen PY, Yashar C, Poppe MM, Li L, Abou Yehia Z, Vicini FA, Moore D, Dale R, Arthur D, Shah C, Haffty BG, Kuske R. Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):67-74. doi: 10.1016/j.ijrobp.2018.12.050. Epub 2019 Jan 4.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2015
• Primary Completion (Actual): August 18, 2017
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Carcinoma in Situ; Breast Neoplasms; Carcinoma; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast
• Other Study ID Numbers: 041404 (Rutgers Cancer Institute of New Jersey); Pro20150001297 (Other Identifier: Rutgers Cancer Institute of New Jersey); NCI-2015-01156 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes