Condition category
Cancer
Date applied
08/10/2012
Date assigned
10/10/2012
Last edited
15/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Jayant Vaidya

ORCID ID

Contact details

Clinical Trials Group
UCL Medical School
Centre for Clinical Science and Technology
Clerkenwell Building
Archway Campus
Highgate Hill
London
N19 5LW
United Kingdom
jayant.vaidya@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01792726

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

Acronym

TARGIT-B

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 post-operative external beam radiotherapy boost in women undergoing breast conserving therapy who have a higher risk of local recurrence.

Please note that as of 14/05/2013, Australia, Canada, Denmark, France, Germany, Italy, Norway, Poland, Switzerland, and the USA were added to the countries of recruitment.

More details can be found at http://www.hta.ac.uk/project/2946.asp

Study protocol can be found at: http://www.hta.ac.uk/protocols/201001040007.pdf

Ethics approval

Not provided at time of registration

Study design

Pragmatic multi-centre randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Early breast cancer

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/03/2013

Overall trial end date

01/03/2022

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Female

Target number of participants

1796

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

01/03/2013

Recruitment end date

01/03/2022

Locations

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
London
N19 5LW
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

JRO
1st Floor
Maple House
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
alka.mistry@uclh.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) ref:10/104/07

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes