Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer

  • End date
    Sep 23, 2023
  • participants needed
  • sponsor
    Shayna Showalter, MD
Updated on 23 January 2021
breast cancer staging
breast-conserving surgery
early-stage breast cancer


The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.


This is a prospective single-arm phase II study designed to study the efficacy of high dose rate (HDR) brachytherapy with CT-imaging, single-fraction intraoperative radiation therapy (IORT). The study will accrue patients with early-stage breast cancer who will be treated with breast-conserving surgery (BCS). The main clinical eligibility criterion is based on suitability for accelerated partial breast irradiation. Patients may be eligible prior to receiving BCS or within 30 days of receiving BCS. Eligible patients that will undergo BCS will receive surgery according to the standard clinical practice in the Brachytherapy Suite in the Emily Couric Clinical Cancer Center. Patients that have already undergone BCS must meet all other eligibility criteria and are able to be treated with IORT within 30 days of their breast surgery. Eligible subjects will undergo a lumpectomy or re-excision lumpectomy according the standard clinical practice. Immediately following lumpectomy, the breast HDR brachytherapy applicator will be placed and CT imaging will be performed for treatment planning. After HDR brachytherapy is delivered, the applicator will be removed, and the breast surgeon will complete the skin closure. Although the ultimate goal of the study is to determine 5-year ipsilateral breast tumor recurrence (IBTR), all efforts will be made to follow the patients until death.

Condition Breast Cancer, Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment IORT with CT-Guided HDR Brachytherapy
Clinical Study IdentifierNCT02400658
SponsorShayna Showalter, MD
Last Modified on23 January 2021


Yes No Not Sure

Inclusion Criteria

Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer
Tumor size must be less than or equal to 3 cm
Patient is 45 years of age or older

Exclusion Criteria

Male patients
Pregnant patients
Breast cancer that involves the skin or chest wall
History of ipsilateral breast cancer
Multicentric breast cancer in the ipsilateral breast
Known BRCA gene mutation
Patient with nodal disease
Patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size
Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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