Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Contact information



Primary contact

Dr Jayant Vaidya


Contact details

Clinical Trials Group
UCL Medical School
Centre for Clinical Science and Technology
Clerkenwell Building
Archway Campus
Highgate Hill
N19 5LW
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number

HTA 0/104/07, TARGIT Boost

Study information

Scientific title

TARGIT-B: An international randomised controlled trial to compare targeted intra-operative radiotherapy boost with conventional external beam radiotherapy boost after lumpectomy for breast cancer in women with a high risk of local recurrence



Study hypothesis

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 treated breast compared with standard postoperative external beam radiotherapy boost in women undergoing breast-conserving therapy who have a higher risk of local recurrence.

More details can be found at

Study protocol can be found at:

Ethics approval

Approved 31/01/2013, REC - Hampshire B (Formally NRES Committee South Central Portsmouth, Bristol HRA Centre, Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8045;, REC ref: 12/SC/0731(transferred from 13/LO/0083)

Study design

Pragmatic multi-centre randomised clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Early breast cancer


Eligible patients are those with a higher risk (8% at 5 years) of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or external beam radiotherapy (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 five years and then annually.

Experimental arm (TARGIT boost):
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.

Control arm (external beam boost):
Standard post-operative external beam radiotherapy boost.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Local recurrence

Secondary outcome measures

1. Site of relapse within the breast
2. Relapse free survival and overall survival and
3. Local toxicity / morbidity

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Patients diagnosed with breast cancer and suitable for conserving surgery and radiotherapy, with a cytological or histological confirmation of carcinoma can be included in the study once a written informed consent is obtained. All patients should be available for regular follow-up (according to local policies) for at least ten years.
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:
2.1. Lymphovascular invasion
2.2. Gross nodal involvement (not micrometastasis)
2.3. 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
3.1. ER negative
3.2. Grade 3 histology
3.3. 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 combination of high risk factors are present (as predefined in the policy document) that give a high risk of local recurrence

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

Australia, Canada, Denmark, France, Germany, Italy, Norway, Poland, Switzerland, United Kingdom, United States of America

Trial participating centre

Clinical Trials Group, UCL Medical School
N19 5LW
United Kingdom

Sponsor information


University College London (UK)

Sponsor details

1st Floor
Maple House
149 Tottenham Court Road
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research Health Technology Assessment Programme - HTA (UK) ref:10/104/07

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date


Participant level data


Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/09/2020: The following changes were made to the trial record: 1. Ethics approval details, publication and dissemination plan, intention to publish date and IPD sharing statement added. 2. The overall trial end date was changed from 01/03/2022 to 30/04/2023. 3. Uploaded protocol Version 7.0, 15 November 2019 (not peer reviewed). 14/05/2013: Australia, Canada, Denmark, France, Germany, Italy, Norway, Poland, Switzerland, and the USA were added to the countries of recruitment.