PHOENIX

• Research type

  Research Study

• Full title

  PHOENIX Trial: A pre-surgical window of opportunity and post-surgical adjuvant biomarker study of DNA damage response inhibition and/or anti-PD-L1 immunotherapy in patients with neoadjuvant chemotherapy resistant residual triple negative breast cancer

• IRAS ID

  249774

• Contact name

  Andrew Tutt

• Contact email

  andrew.tutt@icr.ac.uk

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2018-002077-21

• ISRCTN Number

  ISRCTN47127434

• Clinicaltrials.gov Identifier

  NCT03740893

• Duration of Study in the UK

  4 years, 6 months, 29 days

• Research summary

  Triple negative breast cancer (TNBC) can have a high/moderate risk of returning (relapsing) after standard treatment; usually within the first 2 years after finishing treatment. In some patients with TNBC who receive chemotherapy before surgery, if there is cancer remaining after chemotherapy (called residual disease) that risk of relapse is higher.

  PHOENIX aims to investigate the biology of this residual disease in the 2-week time window between completing chemotherapy and surgery to see if giving trial treatment in this window changes the biology of the cancer.

  TNBC patients who have cancer remaining at their mid-point assessment during chemotherapy will be invited to register for PHOENIX. After registration, a post-chemotherapy MRI scan will confirm presence of residual disease and eligible patients will be randomly allocated into a cohort:

  Cohort A: standard care (no trial treatment)
  Cohort B: AZD6738
  Cohort C: olaparib
  Cohort D: durvalumab

  A pre-treatment research biopsy and blood sample will be collected, followed by trial treatment before surgery. After trial treatment, a second research biopsy and blood sample will be collected. Pre- and post-treatment samples will be compared to see if there is a difference that may provide an early signal that warrants further investigation of the trial treatment.

  Patients may resume trial treatment after surgery for a period of 12 months (adjuvant treatment) to investigate whether any signals seen in the tumour/blood after short exposure to trial treatment prior to surgery are also seen after longer exposure to trial treatment in the adjuvant setting.

• REC name

  London - South East Research Ethics Committee

• REC reference

  19/LO/0127

• Date of REC Opinion

  18 Apr 2019

• REC opinion

  Further Information Favourable Opinion