A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer.

Status unconfirmed · Not applicable

Conditions studied: Early Breast Cancer

In brief

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.

Key facts

Study ID

NCT01792726

Run by

University College, London

People needed

1796

Starts

2013-06-01

Expected to finish

2022-04-01

Last updated by the study team

2019-07-12

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hampshire Hospitals NHS Foundation Trust — Winchester, United Kingdom (enrolling)
• The Great Western Hospital — Swindon, United Kingdom (enrolling)
• Helen Rey Breast Cancer Research Foundation — Los Angeles, California, United States (enrolling)
• Beaumont Health - Royal Oak — Detroit, Michigan, United States (enrolling)
• Lakeland Regional Health System — Saint Joseph, Michigan, United States (enrolling)
• Ashikari Breast Center — Dobbs Ferry, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• West Virginia University — Morgantown, West Virginia, United States (enrolling)
• Aurora Breast Center — Green Bay, Wisconsin, United States (enrolling)
• Beijing Cancer Hospital — Beijing, China (enrolling)
• Institut Bergonié — Bordeaux, France (enrolling)
• Centre François Baclesse — Caen, France (enrolling)
• Centre Georges François Leclerc — Dijon, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• Hôpital Nord — Marseille, France (enrolling)
• Institut de Cancerologie de l'Ouest site René Gauducheau — Nantes, France (enrolling)
• Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (enrolling)
• Centro Di Riferimento Oncologico Di Aviano — Aviano, Italy (enrolling)
• Istituto Oncologico Veneto — Padova, Italy (enrolling)
• University Malaya Medical Centre — Kuala Lumpur, Malaysia (enrolling)
• University of Dammam — Dammam, Saudi Arabia (enrolling)
• Netcare Milpark Hospital — Johannesburg, South Africa (enrolling)
• Gangnam Severance Hospital — Seoul, South Korea (enrolling)
• Institut Català d'Oncologia — Barcelona, Spain (enrolling)
• Hospital Universitario Dr Negrín — Las Palmas de Gran Canaria, Spain (enrolling)

Full record on ClinicalTrials.gov

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