Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
The purpose of this study is to create a registry to evaluate the use of intra-operative
 radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given
 intra-operatively as a single fraction after breast conserving surgery,
A registry trial has been designed and modeled after the original successful TARGIT protocol,
 to continue the use of IORT for a select population of women, and to follow outcomes with
 regards to local and regional control, toxicity and morbidity. Patients selected for breast
 conserving surgery, who are considered to have a low risk of local recurrence, are eligible
 for this registry trial once their informed consent is obtained. This single arm cohort study
 allows entry of patients who have been diagnosed with early stage breast cancer and whose
 clinical stage is suitable for treating conservatively (small tumor and no gross nodal
 involvement). Tumors should not be more than 3.5 cm in size.
Inclusion Criteria:

 -  Female

 -  Age 45 or greater

 -  Diagnosed with operable invasive breast cancer, T1 and T2 (< 3.5 cm), N0, M0,
 confirmed by cytological or histological examination

 -  Suited for breast conserving surgery

 -  Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12
 months of enrollment

 Exclusion Criteria:

 -  age 44 or less

 -  Axillary lymph node positive breast cancer

 -  Invasive lobular cancer

 -  Tumor size > 3.5 cm

 -  Extensive Intraductal Component (EIC= > 25% of the lumpectomy specimen involved with
 ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen

 -  Multicentric cancer in the same breast not amenable to excision with a single
 lumpectomy

 -  Inability to assess pathologic margin status

 -  Synchronous bilateral breast cancer at the time of diagnosis.

 -  Ipsilateral breast had a previous cancer and/or prior in-field radiation.

 -  Patients known to have BRCA1/2 gene mutations

 -  Neoadjuvant treatment (hormones or chemotherapy)