Clinical trial NCT02364960: Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
Official title: Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Early Stage Breast Cancer
Neoplasm of the Breast
Breast Tumor
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
Collaborators: name: TriHealth Hatton Research Institute
name: Bethesda North Hospital Foundation
First posted: 2015-02-18
Enrollment: 16
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, aged 45 and greater who have been diagnosed with early stage invasive breast cancer that is suitable for breast conserving surgery.

Brief summary: 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,

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: In-breast local failure and patterns of in-breast failure
timeFrame: 6 months after IORT through year 10
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Mary Jo Cropper Family Center for Breast Care
state: Ohio
Study officials:
affiliation: Mary Jo Cropper Family Center for Breast Care
name: Ching Ho, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: