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

Rutgers The State University of New Jersey

Status and phase

Completed

Phase 2

Conditions

Stage IB Breast Cancer

Invasive Breast Carcinoma

Progesterone Receptor Positive

Stage IIA Breast Cancer

Stage IA Breast Cancer

Estrogen Receptor Positive

Ductal Breast Carcinoma In Situ

Treatments

Other: Questionnaire Administration

Radiation: Accelerated Partial Breast Irradiation

Radiation: High-Dose Rate Brachytherapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02526498

041404 (Other Identifier)

NCI-2015-01156 (Registry Identifier)

Pro20150001297 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

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