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

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02526498
• Collaborator: Rutgers Cancer Institute of New Jersey (Other), Cianna Medical, Inc. (Industry), Elekta Limited (Industry)
• Enrollment: 200
• Locations: 10
• Arm: 1
• Duration (Months): 91
• Patients Per Site: 20
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Radiation: Accelerated Partial Breast Irradiation; Radiation: High-Dose Rate Brachytherapy; Other: Questionnaire Administration	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

2. 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 Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TRI-fraction Radiotherapy Utilized to Minimize Patient Hospital Trips : A Phase II Trial (TRIUMPH-T Trial)
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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.	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; Other: Questionnaire Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. 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 [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.

Secondary Outcome Measures

1. Local Control Rate, Assessed by Physical Examination [3 years]

   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.

2. Percentage of Patients With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale [2 years]

   Fisher's exact test will be performed to correlate clinical-pathological covariates with toxicity and with cosmesis. Associations between dichotomous cosmetic outcomes (excellent/good versus fair/poor) and treatment related variables will be explored.

3. Local Control Rate, Assessed by Mammography [3 years]

   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.

4. Percentage of Patients With Good/Excellent Cosmetic Results, Using the Breast Cancer Treatment Outcome Scale [2 years]

   Fisher's exact test will be performed to correlate clinical-pathological covariates with toxicity and with cosmesis. Associations between dichotomous cosmetic outcomes (excellent/good versus fair/poor) and treatment related variables will be explored.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Breast Cancer	Gilbert	Arizona	United States	85297
2	University of California, San Diego	La Jolla	California	United States	92093
3	William Beaumont Hospital Research Institute	Royal Oak	Michigan	United States	48073
4	RWJBarnabas Health - Robert Wood Johnson University Hospital	New Brunswick	New Jersey	United States	08901
5	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
6	Montefiore Medical Center	Bronx	New York	United States	10461
7	21st Centry Oncolgy	Yonkers	New York	United States	10457
8	Cleveland Clinic	Cleveland	Ohio	United States	44106
9	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
10	Huntsman Cancer Hospital, University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• Rutgers Cancer Institute of New Jersey
• Cianna Medical, Inc.
• Elekta Limited

Investigators

• Principal Investigator: Bruce Haffty, MD, Rutgers Cancer Institute of New Jersey

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Nov 17, 2021

More Information

Publications

None provided.

• Responsible Party: Bruce G Haffty, Principal Investigator, Rutgers Cancer Institute of New Jersey
• ClinicalTrials.gov Identifier: NCT02526498
• Other Study ID Numbers: Pro20150001297; NCI-2015-01156; Pro20150001297; 041404
• First Posted: Aug 18, 2015
• Last Update Posted: Aug 16, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Study Results

Participant Flow

Arm/Group Title	Treatment (APBI Using HDR Brachytherapy)
Arm/Group Description	Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
Period Title: Overall Study
STARTED	200
COMPLETED	200
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment (APBI Using HDR Brachytherapy)
Arm/Group Description	Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
Overall Participants	200
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	65 32.5%
>=65 years	135 67.5%
Sex: Female, Male (Count of Participants)
Female	200 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 5.5%
Not Hispanic or Latino	189 94.5%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.5%
Asian	7 3.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 3.5%
White	185 92.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	200 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (APBI Using HDR Brachytherapy)
Arm/Group Description	Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
Measure Participants	200
Count of Participants [Participants]	200 100%

2. Secondary Outcome

Title	Local Control Rate, Assessed by Physical Examination
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Percentage of Patients With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale
Description	Fisher's exact test will be performed to correlate clinical-pathological covariates with toxicity and with cosmesis. Associations between dichotomous cosmetic outcomes (excellent/good versus fair/poor) and treatment related variables will be explored.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Local Control Rate, Assessed by Mammography
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Percentage of Patients With Good/Excellent Cosmetic Results, Using the Breast Cancer Treatment Outcome Scale
Description	Fisher's exact test will be performed to correlate clinical-pathological covariates with toxicity and with cosmesis. Associations between dichotomous cosmetic outcomes (excellent/good versus fair/poor) and treatment related variables will be explored.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events were collected over a period of two years.
Arm/Group Title	Treatment (APBI Using HDR Brachytherapy)
Arm/Group Description	Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies
All Cause Mortality
	Treatment (APBI Using HDR Brachytherapy)
	Affected / at Risk (%)	# Events
Total	0/200 (0%)
Serious Adverse Events
	Treatment (APBI Using HDR Brachytherapy)
	Affected / at Risk (%)	# Events
Total	0/200 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (APBI Using HDR Brachytherapy)
	Affected / at Risk (%)	# Events
Total	165/200 (82.5%)
General disorders
Breast Pain	30/200 (15%)	38
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	39/200 (19.5%)	42
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	44/200 (22%)	58
Fibrosis deep connective tissue	29/200 (14.5%)	37
Superficial soft tissue fibrosis	19/200 (9.5%)	19
Reproductive system and breast disorders
Reproductive system and breast disorder	35/200 (17.5%)	41
Skin and subcutaneous tissue disorders
Dermatitis radiation	29/200 (14.5%)	32
Seroma	11/200 (5.5%)	11
Skin and subcutaneous tissue disorders	10/200 (5%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.