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

Invasive Breast Carcinoma Clinical Trial

— TRIUMPH-T  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526498
• Other study ID #: 041404
• Secondary ID: NCI-2015-01156Pr
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 2015
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 31, 2021
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• 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

Intervention

Radiation:
• 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

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Cleveland Clinic	Cleveland	Ohio
United States	Arizona Breast Cancer	Gilbert	Arizona
United States	University of California, San Diego	La Jolla	California
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	RWJBarnabas Health - Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	William Beaumont Hospital Research Institute	Royal Oak	Michigan
United States	Huntsman Cancer Hospital, University of Utah	Salt Lake City	Utah
United States	21st Centry Oncolgy	Yonkers	New York

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale	Descriptive statistics reported.	2 years
Secondary	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