Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)

Stopped early

Conditions studied: Early Stage Breast Cancer, Neoplasm of the Breast, Breast Tumor

In brief

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,

Key facts

Study ID

NCT02364960

Run by

TriHealth Inc.

People needed

16

Starts

2015-01-01

Expected to finish

2016-01-01

Last updated by the study team

2018-08-22

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mary Jo Cropper Family Center for Breast Care — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.