Ductal Breast Carcinoma In SituPhase 2TRIUMPH-TNCT02526498

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

A Phase 2 study testing Accelerated Partial Breast Irradiation, High-Dose Rate Brachytherapy and Questionnaire Administration in people with Ductal Breast Carcinoma In Situ and Estrogen Receptor Positive, run by Rutgers, The State University of New Jersey at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 years and older, women only
Conditions the study is for: Ductal Breast Carcinoma In Situ, Estrogen Receptor Positive, Invasive Breast Carcinoma
What is being tested?: Accelerated Partial Breast Irradiation, High-Dose Rate Brachytherapy and Questionnaire Administration
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 10 sitesUnited States
Study dates: 15 Jul 2015to 31 Mar 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 12Show fewer

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

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

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

To determine the toxicity rate with shorter courses of accelerated partial breast irradiation (APBI) delivered with a breast brachytherapy applicator.

SECONDARY OBJECTIVES:

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
Being tested: Accelerated Partial Breast Irradiation, High-Dose Rate Brachytherapy, Questionnaire Administration
Medical subject headings: Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Accelerated Partial Breast IrradiationRadiation
Also called APBI
Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy
High-Dose Rate BrachytherapyRadiation
Undergo APBI using HDR brachytherapy
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT02526498
Study group	Role	What they receive
Treatment (APBI using HDR brachytherapy)	Experimental	Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Receives: Radiation: Accelerated Partial Breast Irradiation; Radiation: High-Dose Rate Brachytherapy; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years

Secondary outcomes (3)

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.
Measured: 3 years
Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale
Descriptive statistics reported.
Measured: 2 years
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.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201531 Mar 2021

First posted18 Aug 2015 (estimated)
Study start15 Jul 2015
Primary completion18 Aug 2017
Study completion31 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ductal Breast Carcinoma In SituStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02526498
Sponsor's protocol ID: 041404
Other IDs: NCI-2015-01156, Pro20150001297, Pro20150001297
Acronym: TRIUMPH-T
Status last verified: Apr 2023
First submitted: 4 Aug 2015
Last updated: 15 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 30611839

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ductal Breast Carcinoma In Situ trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TRI-fraction Radiotherapy Utilized to Minimize Patient Hospital Trips : A Phase II Trial (TRIUMPH-T Trial)
ClinicalTrials.gov ID: NCT02526498
Acronym / sponsor ID: TRIUMPH-T / 041404
Conditions: Ductal Breast Carcinoma In Situ, Estrogen Receptor Positive, Invasive Breast Carcinoma, Progesterone Receptor Positive, Stage IA Breast Cancer, Stage IB Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: Rutgers Cancer Institute of New Jersey, Cianna Medical, Inc., Elekta Limited
Study start: 15 Jul 2015 (actual)
Primary completion: 18 Aug 2017 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 18 Aug 2015 (estimated)
Results: Posted 16 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the toxicity rate with shorter courses of accelerated partial breast irradiation (APBI) delivered with a breast brachytherapy applicator.

SECONDARY OBJECTIVES:

To determine the 3-year actuarial local control rate with abbreviated accelerated partial breast irradiation (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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (APBI using HDR brachytherapy)	Experimental	Radiation: Accelerated Partial Breast Irradiation, Radiation: High-Dose Rate Brachytherapy, Other: Questionnaire AdministrationWithin 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days.

Who may qualify

Ages: 45 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Accelerated Partial Breast IrradiationAlso: APBIUndergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy	Radiation	Treatment (APBI using HDR brachytherapy)
High-Dose Rate BrachytherapyUndergo APBI using HDR brachytherapy	Radiation	Treatment (APBI using HDR brachytherapy)
Questionnaire AdministrationAncillary studies	Other	Treatment (APBI using HDR brachytherapy)

Primary outcome

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
Time frame: 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.

3 secondary outcomes

Local Control Rate, Assessed by Physical Examination
Time frame: 3 years
Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale
Time frame: 2 years
Local Control Rate, Assessed by Mammography
Time frame: 3 years

Results and safety

Results posted to the registry on 16 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (APBI Using HDR Brachytherapy)	200	200

Primary outcome: 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

Time frame: 2 years. Count of participants. Unit: Participants

Measure	Treatment (APBI Using HDR Brachytherapy) n = 200
Value	200

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over a period of two years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (APBI Using HDR Brachytherapy)	0 of 200 (0%)	165 of 200 (82.5%)	0 of 200

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30611839Khan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce Haffty, MD principal investigator

Rutgers Cancer Institute of New Jersey

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02526498, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.