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Brachytherapy

Accelerated Partial Breast Irradiation for Breast Cancer (TRIUMPH-T Trial)

Phase 2

Waitlist Available

Led By Bruce Haffty, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

TRIUMPH-T Trial Summary

This trial looks at how well a shorter, higher-dose radiation therapy works in treating early-stage breast cancer.

Eligible Conditions

Breast Cancer
No change needed.
Progesterone Receptor Positive

TRIUMPH-T Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Local Control Rate, Assessed by Mammography

Local Control Rate, Assessed by Physical Examination

Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale

Side effects data

From 2021 Phase 2 trial • 200 Patients • NCT02526498

22%

Musculoskeletal and connective tissue disorders

20%

Injury, poisoning and procedural complications

18%

Reproductive system and breast disorder

15%

Breast Pain

14%

Dermatitis radiation

14%

Fibrosis deep connective tissue

10%

Superficial soft tissue fibrosis

Seroma

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (APBI Using HDR Brachytherapy)

TRIUMPH-T Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (APBI using HDR brachytherapy)Experimental Treatment3 Interventions

Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Accelerated Partial Breast Irradiation

2015

Completed Phase 2

~200

High-Dose Rate Brachytherapy

2004

Completed Phase 2

~530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,068 Total Patients Enrolled

16 Trials studying Breast Cancer

1,910 Patients Enrolled for Breast Cancer

Rutgers Cancer Institute of New JerseyOTHER

70 Previous Clinical Trials

18,557 Total Patients Enrolled

8 Trials studying Breast Cancer

1,923 Patients Enrolled for Breast Cancer

Cianna Medical, Inc.Industry Sponsor

3 Previous Clinical Trials

185 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographic areas is this experimental protocol being conducted?

"The research is being conducted at Rutgers Cancer Institute of New jersey in New Brunswick, Huntsman Cancer Hospital, University of Utah in Salt Lake City and the University of California San Diego in La Jolla. Additionally, there are 10 other medical centres taking part in this trial."

Answered by AI

How secure is the Accelerated Partial Breast Irradiation process for patients?

"This Phase 2 trial has produced evidence suggesting that Accelerated Partial Breast Irradiation is safe, resulting in a score of 2. However, there have been no studies conducted to verify its efficacy."

Answered by AI

What are the anticipated results of this medical investigation?

"This 2 year clinical trial seeks to analyse the Serious toxicity rate through Common Terminology Criteria for Adverse Events version 4.0 criteria, evaluate the Local control rate with physical examination and mammography using Kaplan-Meier method, as well as assess Percentage of patients with good/excellent cosmetic results via Fisher's exact test from Breast cancer Treatment Outcome Scale. Statistically significant tests will be determined if P-value is lower than or equal to 0.05 in a two sided testing procedure."

Answered by AI

Are there any vacancies available to join this research program?

"Per the information hosted on clinicaltrials.gov, recruitment for this specific study has been halted since July 20th 2022 - when it was last edited. Nevertheless, there are 4600 other trials actively recruiting patients across the world at present."

Answered by AI

Recent research and studies

International Journal of Radiation Oncology*Biology*PhysicsJournal

Three-fraction Accelerated Partial Breast Irradiation (APBI) Delivered with Brachytherapy Applicators Is Feasible and Safe: First Results from the TRIUMPH-T Trial

Khan, Atif J., Peter Y. Chen, Catheryn Yashar, Matthew M. Poppe, Linna Li, Zeinab Abou Yehia, Frank A. Vicini, et al.. 2019. “Three-fraction Accelerated Partial Breast Irradiation (APBI) Delivered with Brachytherapy Applicators Is Feasible and Safe: First Results from the TRIUMPH-T Trial”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2018.12.050.

clinicaltrials.govStudy

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

Bruce G Haffty 2015. "Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02526498.