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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02526498

Run by

Rutgers, The State University of New Jersey

People needed

200

Starts

2015-07-15

Expected to finish

2021-03-31

Last updated by the study team

2023-05-15

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

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

Full record on ClinicalTrials.gov

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