Status:
UNKNOWN
A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer.
Lead Sponsor:
University College, London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Early Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
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 su...
Detailed Description
DESIGN: A pragmatic multi-centre randomised clinical trial to test whether TARGeted Intraoperative radioTherapy as a tumour bed Boost (TARGIT-B) is superior in terms of local relapse within the treate...
Eligibility Criteria
Inclusion
- At least one of these criteria must be satisfied:
- Less than 46 years of age
- More than 45 years of age, but with one of the following poor prognostic factors:
- lymphovascular invasion
- gross nodal involvement (not micrometastasis)
- more than one tumour in the breast but still suitable for breast conserving surgery through a single specimen
- More than 45 years of age, but with at least two of the following poor prognostic factors
- ER and/or PgR negative
- Grade 3 histology
- Positive margins at first excision
- Those patients with large tumours which have responded to neo-adjuvant chemo- or hormone therapy in an attempt to shrink the tumour and are suitable for breast conserving surgery as a result.
- Lobular carcinoma or Extensive Intraductal Component (EIC)
- A list (one to many) of high risk factors are present (as predefined in the policy document) that give a high risk of local recurrence.
- Patients with either HER2 positive or HER2 negative can be included.
Exclusion
- 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 relapse-free survival at 10 years is 90% or greater (e.g., non-melanoma skin cancer, CIN, etc).
- No more than 30 days can have elapsed between last breast cancer surgery (not axillary) and randomisation for patients in the post-pathology stratification unless part of a specific clinical trial that addresses the question of timing or tumour bed can be reliably identified, e.g., by ultrasound.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
1796 Patients enrolled
Trial Details
Trial ID
NCT01792726
Start Date
June 1 2013
End Date
April 1 2022
Last Update
July 12 2019
Active Locations (34)
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1
Helen Rey Breast Cancer Research Foundation
Los Angeles, California, United States
2
Memorial Health University Medical Center
Savannah, Georgia, United States
3
Beaumont Health - Royal Oak
Detroit, Michigan, United States
4
Lakeland Regional Health System
Saint Joseph, Michigan, United States