TARGIT-B Extension

  • Research type

    Research Study

  • Full title

    Extended follow up of the TARGIT-B trial: 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

  • IRAS ID

    353406

  • Contact name

    Jayant S Vaidya

  • Contact email

    jayant.vaidya@ucl.ac.uk

  • Sponsor organisation

    British Association of Surgical Oncology ~ Association of Cancer Surgeons

  • Duration of Study in the UK

    7 years, 3 months, 31 days

  • Research summary

    This study will continue follow-up of patients in the TARGIT-B trial (described below) in order to obtain the data necessary for robust analysis and comparison of the two treatments to which these patients were randomised. This extension study is limited to collection of data obtained in clinical care. Patient-level data will be linked with that collected from patients in the original TARGIT-B trial to ensure the fuller longitudinal dataset needed for meaningful comparative analyses.

    TARGIT-B trial was 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 was a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial.
    All patients participating received whole breast EBRT and other adjuvant treatments as deemed necessary.

    TARGIT-B funding came to an end, cutting short the follow-up planned to be up to 10 years. The recommended length of follow up was at least 5 years. The original trial has only 4.2 years of median data follow-up, thus the need for this further data collection and analysis. Participants will be asked for consent to provide their original study data to TARGIT-B extension in a form that will allow it to be aggregated with data collected in this study.

  • REC name

    Wales REC 7

  • REC reference

    25/WA/0272

  • Date of REC Opinion

    4 Sep 2025

  • REC opinion

    Favourable Opinion