A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer. (TARGIT-B)
Early Breast Cancer
About this trial
This is an interventional treatment trial for Early Breast Cancer focused on measuring breast cancer, radiotherapy, TARGIT, Intrabeam
Eligibility Criteria
Inclusion Criteria:
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 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 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.
Sites / Locations
- Helen Rey Breast Cancer Research FoundationRecruiting
- Memorial Health University Medical Center
- Beaumont Health - Royal OakRecruiting
- Lakeland Regional Health SystemRecruiting
- Ashikari Breast CenterRecruiting
- Cleveland ClinicRecruiting
- West Virginia UniversityRecruiting
- Aurora Breast CenterRecruiting
- Beijing Cancer HospitalRecruiting
- Institut BergoniéRecruiting
- Centre François BaclesseRecruiting
- Centre Georges François LeclercRecruiting
- Centre Léon BérardRecruiting
- Hôpital NordRecruiting
- Institut de Cancerologie de l'Ouest site René GauducheauRecruiting
- Institut Universitaire du Cancer de Toulouse - OncopoleRecruiting
- Centro Di Riferimento Oncologico Di AvianoRecruiting
- Istituto Oncologico VenetoRecruiting
- Gangnam Severance HospitalRecruiting
- University Malaya Medical CentreRecruiting
- University of DammamRecruiting
- Netcare Milpark HospitalRecruiting
- Institut Català d'OncologiaRecruiting
- Hospital Universitario Dr NegrínRecruiting
- Brust-Zentrum OnkologieRecruiting
- Queen Sirikit Cantre for Breast CancerRecruiting
- Princess Alexandra Hospital NHS TrustRecruiting
- Whittington HospitalRecruiting
- Royal Free London NHS TrustRecruiting
- Guy's HospitalRecruiting
- Hospital of St John and St ElizabethRecruiting
- Princess Grace Hospital
- The Great Western HospitalRecruiting
- Hampshire Hospitals NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
TARGIT
External beam radiotherapy boost
The experimental policy is to give targeted intra-operative radiotherapy (TARGIT-Boost) in a single dose to substitute for the usual boost dose, in addition to whole breast external beam radiotherapy delivered according to local treatment guidelines.
The conventional policy is to receive radiation boost to the tumour bed delivered by external beam radiotherapy (EBRT) in addition to whole breast external beam radiotherapy delivered according to local treatment guidelines.