Summary

Eligibility
for females ages 45 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

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 Carcinoma Breast Neoplasms Carcinoma in Situ Carcinoma, Ductal, Breast Breast Carcinoma In Situ Carcinoma, Intraductal, Noninfiltrating Accelerated Partial Breast Irradiation High-Dose Rate Brachytherapy

Eligibility

You can join if…

Open to females ages 45 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego
    La Jolla California 92093 United States
  • Arizona Breast Cancer
    Gilbert Arizona 85297 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rutgers, The State University of New Jersey
ID
NCT02526498
Phase
Phase 2 research study
Study Type
Interventional
Participants
At least 200 people participating
Last Updated