A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early 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. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.

Study Start Date

June 2013

Estimated Completion Date

April 2022

Interventions

  • Radiation: Boost to the tumour bed

Specialties

  • Obstetrics & Gynecology: Breast
  • Oncology: Breast
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Breast Neoplasms

Study ID

University College London Hospitals -- TARGIT Boost

Status

Recruiting

Trial ID

NCT01792726

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

1796

Sponsor

University College London Hospitals

Inclusion Criteria

    At least one of these criteria must be satisfied: 1. Less than 46 years of age 2. More than 45 years of age, but with one of the following poor prognostic factors: 1. lymphovascular invasion 2. gross nodal involvement (not micrometastasis) 3. more than one tumour in the breast but still suitable for breast conserving surgery through a single specimen 3. More than 45 years of age, but with at least two of the following poor prognostic factors 1. ER and/or PgR negative 2. Grade 3 histology 3. Positive margins at first excision 4. 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. 5. Lobular carcinoma or Extensive Intraductal Component (EIC) 6. 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. 7. Patients with either HER2 positive or HER2 negative can be included.

Exclusion Criteria

    1. Bilateral breast cancer at the time of diagnosis. 2. Patients with any severe concomitant disease that may limit their life expectancy 3. 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). 4. 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.

Gender

Female

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Ashikari Breast Center - Dobb's Ferry, New York 35.1 miles Pond Kelemen MD None None

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