TARGeted Intraoperative radioTherapy as a tumour bed Boost (TARGIT-B): 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
| ISRCTN | ISRCTN43138042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43138042 |
| ClinicalTrials.gov number | NCT01792726 |
| Secondary identifying numbers | HTA 0/104/07, TARGIT Boost |
- Submission date
- 08/10/2012
- Registration date
- 10/10/2012
- Last edited
- 01/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Dr Jayant Vaidya
Principal Investigator
Principal Investigator
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 |
Study information
| Study design | Pragmatic multi-centre randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 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 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 http://www.hta.ac.uk/project/2946.asp Study protocol can be found at: http://www.hta.ac.uk/protocols/201001040007.pdf |
| Ethics approval(s) | 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; nrescommittee.southcentral-hampshireb@nhs.net), REC ref: 12/SC/0731(transferred from 13/LO/0083) |
| Condition | Early breast cancer |
| Intervention | Current interventions as of 09/05/2024: 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 6 monthly intervals for five years and then annually for at least 10 years. 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. Previous interventions: 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 6 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 |
| Primary outcome measure | Local recurrence |
| Secondary outcome measures | 1. Site of relapse within the breast 2. Relapse-free survival and overall survival 3. Local toxicity/morbidity |
| Overall study start date | 01/03/2013 |
| Overall study end date | 31/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1796 |
| Total final enrolment | 1684 |
| 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 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 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 | 14/06/2023 |
Locations
Countries of recruitment
- Australia
- Canada
- Denmark
- England
- France
- Germany
- Italy
- Norway
- Poland
- Switzerland
- United Kingdom
- United States of America
Study participating centre
Clinical Trials Group, UCL Medical School
London
N19 5LW
United Kingdom
N19 5LW
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
JRO, 1st Floor, Maple House
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom
| alka.mistry@uclh.nhs.uk | |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
National Institute for Health Research Health Technology Assessment Programme - HTA (UK) ref:10/104/07
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V7.0 | 15/11/2019 | 11/09/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN43138042_PROTOCOL_V7.0_15Nov19.pdf
- Uploaded 11/09/2020
Editorial Notes
01/11/2024: The overall end date was changed from 31/12/2032 to 31/10/2024.
09/05/2024: The following changes were made to the study record:
1. The interventions and plain English summary link were updated.
2. The overall study end date was changed from 31/10/2024 to 31/12/2032.
3. Study website added.
18/04/2024: The following changes were made to the trial record:
1. The overall study end date was changed from 30/04/2023 to 31/10/2024.
2. The intention to publish date was changed from 30/04/2024 to 30/04/2026.
3. The total final enrolment was added.
4. The recruitment end date was changed from 01/03/2022 to 14/06/2023.
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.
