NCT02526498: TRIUMPH-T

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

Completed Phase 2 Results posted Last updated 15 May 2023

What this trial tests

Phase 2 trial testing Accelerated Partial Breast Irradiation in Ductal Breast Carcinoma In Situ in 200 participants. Completed in 31 March 2021.

Timeline

15 July 2015

Primary endpoint
18 August 2017

31 March 2021

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	15 July 2015
Primary completion	18 August 2017
Estimated completion	31 March 2021
Sites	10 locations across United States

Drugs / interventions tested

• Accelerated Partial Breast Irradiation — full drug profile →
• High-Dose Rate Brachytherapy
• Questionnaire Administration

Conditions studied

• Ductal Breast Carcinoma In Situ — all drugs for Ductal Breast Carcinoma In Situ →
• Estrogen Receptor Positive — all drugs for Estrogen Receptor Positive →
• Invasive Breast Carcinoma — all drugs for Invasive Breast Carcinoma →
• Progesterone Receptor Positive — all drugs for Progesterone Receptor Positive →

Sponsor

Rutgers, The State University of New Jersey

Who can join

45 and older, female only, with Ductal Breast Carcinoma In Situ or Estrogen Receptor Positive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 2 years

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.

Group	Value	95% CI
Treatment (APBI Using HDR Brachytherapy)	200

Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale Secondary · 2 years

Descriptive statistics reported.

Group	Value	95% CI
Treatment (APBI Using HDR Brachytherapy)	177

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over a period of two years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (APBI Using HDR Brachytherapy)

Serious: 0/200 (0%)

Deaths: 0/200

Other adverse events (9 terms — click to expand)

Reaction	System	Treatment (APBI Using HDR …
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	—
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	—
Reproductive system and breast disorder	Reproductive system and breast disorders	—
Breast Pain	General disorders	—
Fibrosis deep connective tissue	Musculoskeletal and connective tissue disorders	—
Dermatitis radiation	Skin and subcutaneous tissue disorders	—
Superficial soft tissue fibrosis	Musculoskeletal and connective tissue disorders	—
Seroma	Skin and subcutaneous tissue disorders	—
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT02526498 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial.
   Khan AJ, Chen PY, Yashar C, Poppe MM, et al · · 2019 · cited 42× · PMID 30611839 · DOI 10.1016/j.ijrobp.2018.12.050