TARGIT B

Clinical Trial Title TARGeted Intraoperative radioTherapy Boost vs. Postoperative External Beam Radiotherapy boost
Trial Status Open to Enrollment
Start Date 11/09/2020
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Breast Cancer
Description TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial.
Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with breast cancer and suitable for conserving surgery and whole breast radiotherapy, with a histological confirmation of carcinoma can be included in the study once a written informed consent is obtained. All patients should be available for regular follow-up (according to local policies) for at least ten years.
  • Less than 46 years of age
  • More than 45 years of age and with one or more of the following poor prognostic factors:
  •  a) Grade 3
  •  b) ER and/or PgR negative
  •  c) lobular carcinoma
  •  d) extensive intraductal component (EIC)
  •  e) lymphovascular invasion
  •  f) axillary nodal involvement
  •  g) more than one tumour in the breast but still suitable for breast conserving surgery through a single specimen
  •  h) any factor or a combination of factors that puts the patient at a higher risk of local recurrence as per the current local guidelines : e.g., those who need a tumour bed boost or those not suitable for TARGIT-Alone as standard treatment.

Exclusion Criteria

  • Bilateral breast cancer at the time of diagnosis.
  • Patients with any severe concomitant disease that may limit their life expectancy
  • Previous history of malignant disease does not preclude entry if the expectation of relapsefree survival at 10 years is 90% or greater

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT01792726?term=targit+b
Principal Investigator Mark Schray, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org