Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 8/11/2018 |
| Start Date: | June 2015 |
| End Date: | December 2020 |
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.
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.
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.
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.
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
We found this trial at
1
site
New Brunswick, New Jersey 08903
Principal Investigator: Atif Khan
Phone: 732-235-8675
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