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

NCT01792726 | Unknown DMC

• 2 other identifiers: TARGIT BoostNHS NIHR HTA
• Study Type: interventional
• Target: 1,796
• Locations: 12 countries
• Sites: 34

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 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.

Conditions

Early Breast Cancer

Keywords

breast cancer; radiotherapy; TARGIT; Intrabeam

Outcome Measures

Primary Outcomes (1)

• Local tumour control (defined as no recurrent tumour in the ipsilateral breast).

  To evaluate whether a tumour bed boost in the form of a single fraction of radiotherapy given intra-operatively and targeted to the tissues at the highest risk of local recurrence is superior (in terms of local tumour control) to standard post-operative external beam radiotherapy boost, after breast conserving surgery in women undergoing breast conserving therapy who have a higher risk of local recurrence.

  Five year median follow-up

Secondary Outcomes (5)

• Site of relapse within the treated breast

  5 years median follow-up

• Relapse-free survival

  Five year median follow-up

• Overall survival

  Five year median follow-up.

• Adverse events related to the primary treatment of the breast cancer.

  Five year median follow-up.

• Quality of life assessed by patient completed validated questionnaires.

  Five year median follow-up

Study Arms (2)

TARGIT

EXPERIMENTAL

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.

Radiation: Boost to the tumour bed

External beam radiotherapy boost

ACTIVE COMPARATOR

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.

Radiation: Boost to the tumour bed

Interventions

Boost to the tumour bed RADIATION

Boost to the tumour bed, with whole breast EBRT delivered according to local policy.

Also known as: Radiotherapy boost

External beam radiotherapy boost; TARGIT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University College, London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (34)

Helen Rey Breast Cancer Research Foundation

Los Angeles, California, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, United States

ACTIVE NOT RECRUITING

Beaumont Health - Royal Oak

Detroit, Michigan, United States

RECRUITING

Lakeland Regional Health System

Saint Joseph, Michigan, United States

RECRUITING

Ashikari Breast Center

Dobbs Ferry, New York, 10522, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, United States

RECRUITING

Aurora Breast Center

Green Bay, Wisconsin, United States

RECRUITING

Beijing Cancer Hospital

Beijing, China

RECRUITING

Institut Bergonié

Bordeaux, France

RECRUITING

Centre François Baclesse

Caen, France

RECRUITING

Centre Georges François Leclerc

Dijon, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hôpital Nord

Marseille, France

RECRUITING

Institut de Cancerologie de l'Ouest site René Gauducheau

Nantes, 44805, France

RECRUITING

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

RECRUITING

Centro Di Riferimento Oncologico Di Aviano

Aviano, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, Italy

RECRUITING

University Malaya Medical Centre

Kuala Lumpur, Malaysia

RECRUITING

University of Dammam

Dammam, Saudi Arabia

RECRUITING

Netcare Milpark Hospital

Johannesburg, South Africa

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Institut Català d'Oncologia

Barcelona, Spain

RECRUITING

Hospital Universitario Dr Negrín

Las Palmas de Gran Canaria, Spain

RECRUITING

Brust-Zentrum Onkologie

Zurich, Switzerland

RECRUITING

Queen Sirikit Cantre for Breast Cancer

Bangkok, Thailand

RECRUITING

Princess Alexandra Hospital NHS Trust

Harlow, United Kingdom

RECRUITING

Whittington Hospital

London, N19 5NF, United Kingdom

RECRUITING

Royal Free London NHS Trust

London, NW3 2QG, United Kingdom

RECRUITING

Guy's Hospital

London, United Kingdom

RECRUITING

Hospital of St John and St Elizabeth

London, United Kingdom

RECRUITING

Princess Grace Hospital

London, United Kingdom

ACTIVE NOT RECRUITING

The Great Western Hospital

Swindon, SN3 6BB, United Kingdom

RECRUITING

Hampshire Hospitals NHS Foundation Trust

Winchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jayant S Vaidya, MBBS FRCS

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norman R Williams, PhD

CONTACT

+44 (0)20 7679 9280; SITU.TARGITB@ucl.ac.uk

Nick Roberts

CONTACT

+44 (0)20 7679 9280; SITU.TARGITB@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

TH (1); KR (1); ES (2); ZA (1); IT (2); MY (1); US (8); CN (1); SA (1); CH (1); GB (8); FR (7)