This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

BARBICAN

  • Research type

    Research Study

  • Full title

    BARBICAN: A randomised, open-label Phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer

  • IRAS ID

    246119

  • Contact name

    Kelly Mousa

  • Contact email

    bci-barbican@qmul.ac.uk

  • Sponsor organisation

    Queen Mary University of London

  • Eudract number

    2018-000977-62

  • Duration of Study in the UK

    7 years, 1 months, 0 days

  • Research summary

    Triple-negative breast cancer (TNBC) accounts for approximately 20% of all breast cancers. Treatment results remain relatively poor compared to other breast cancer subtypes and new treatment approaches are needed. Chemotherapy is the main type of treatment but benefits are frequently short-lived with rapid development of resistance. Approximately 40% of patients who receive neoadjuvant chemotherapy (NACT – chemotherapy before surgery) achieve a good response at surgery (pathological complete response(pCR)). There is a strong link between pCR and long-term outcome for TNBC. In recent years, significant developments around cancer immunotherapy (CIT) have led to changes in the treatment of cancer. CIT is any treatment that modifies and/or enhances the patient’s immune system to fight cancers. Early results with CIT have shown encouraging activity in TNBC. Combination trials of CIT and chemotherapy have demonstrated high response rates in metastatic disease and high pCR rates in early TNBC, respectively, but experience with other combinations is currently limited. There is increasing data supporting combinations of AKT inhibitors and CIT. \nBARBICAN will be carried out in approximately 142 women with early TNBC in order to assess the effect of adding an AKT inhibitor (ipatasertib) to the combination of NACT and CIT (atezolizumab) in TNBC. Treatment will be given before surgery. To assess the effect of the treatment, breast cancer samples will be collected before, during and on completion of treatment. Pre-treatment samples can be archived tissue but participants will require additional biopsies in this study. Following surgery patients will be followed up as per normal practice for 5 years. There will be no additional study visits in this period but the research team will collect information on disease and survival status during normal hospital visits. The study will be carried out in 3 countries.\n

  • REC name

    London - South East Research Ethics Committee

  • REC reference

    18/LO/1453

  • Date of REC Opinion

    28 Sep 2018

  • REC opinion

    Favourable Opinion