Tucatinib/placebo w/T-DM1 for advanced/metastatic HER2+ breast cancer

  • Research type

    Research Study

  • Full title

    Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer (HER2CLIMB-02)

  • IRAS ID

    281310

  • Contact name

    Alicia Okines

  • Contact email

    alicia.okines@rmh.nhs.uk

  • Sponsor organisation

    Seattle Genetics, Inc.

  • Eudract number

    2019-005017-39

  • Clinicaltrials.gov Identifier

    NCT03975647

  • Clinicaltrials.gov Identifier

    119421 , IND Number

  • Duration of Study in the UK

    4 years, 0 months, 15 days

  • Research summary

    This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.

    All patients will receive T-DM1, a drug that is often used to treat this cancer. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo.

    Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

    This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in subjects with unresectable locally-advanced or metastatic HER2+ breast cancer who have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab treatment is permitted, but not required.

    While on study treatment, subjects will be assessed for progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence of disease progression, subjects in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.

  • REC name

    London - Harrow Research Ethics Committee

  • REC reference

    20/LO/0963

  • Date of REC Opinion

    23 Oct 2020

  • REC opinion

    Further Information Favourable Opinion