plasmaMATCH

  • Research type

    Research Study

  • Full title

    The UK plasma based Molecular profiling of Advanced breast cancer to inform Therapeutic Choices (plasmaMATCH) Trial: A multiple parallel cohort, open-label, multi-centre phase IIa clinical trial aiming to provide proof of principle efficacy for designated targeted therapies in patients with advanced breast cancer where the targetable mutation is identified through ctDNA screening

  • IRAS ID

    187103

  • Contact name

    Sarah Kernaghan

  • Contact email

    plasmamatch-icrctsu@icr.ac.uk

  • Sponsor organisation

    The Institute of Cancer Research

  • Eudract number

    2015-003735-36

  • Duration of Study in the UK

    5 years, 11 months, 30 days

  • Research summary

    There are many different types of breast cancer defined by the genetic code present within cancer cells. The genetic code is stored in the form of DNA, and changes within DNA are called mutations. Mutations are usually identified by analysis of tumour samples obtained through surgery or biopsy. Treatments that target specific mutations (known as targeted therapies) have led to improvements in the treatment of breast cancer.

    DNA from cancer cells is found in the blood of over 90% of patients with advanced breast cancer (breast cancer that has either reappeared following treatment, known as recurrent or locally advanced breast cancer, or breast cancer that has spread to another part of the body, known as metastatic breast cancer). DNA from cancer cells found in the blood is called circulating tumour DNA (ctDNA).

    Patients with advanced breast cancer will be asked to provide a blood sample which will be analysed for several specific mutations in the ctDNA. If a targetable mutation is identified, the patient will be invited to enter a treatment cohort and receive a treatment targeting the specific mutation. Patients will receive treatment until their cancer gets worse (progresses).

    The main aims of plasmaMATCH are to assess whether ctDNA screening can be used to detect patients with targetable mutations and then to assess the safety and activity of the targeted treatments in patients with targetable mutations identified at ctDNA screening.

    Treatment cohorts:
    Cohort A: Patients with an ESR1 mutation will receive extended-dose fulvestrant.
    Cohort B: Patients with a HER2 mutation will receive neratinib. Patients with estrogen receptor (ER) positive breast cancer in this cohort will also receive fulvestrant.
    Cohort C: Patients with ER positive breast cancer and an AKT1 mutation will receive AZD5363 and fulvestrant.
    Cohort D: Patients with one of several mutations that activate a process called the ‘AKT pathway’ will receive AZD5363.

  • REC name

    South Central - Oxford C Research Ethics Committee

  • REC reference

    16/SC/0271

  • Date of REC Opinion

    13 Jun 2016

  • REC opinion

    Favourable Opinion