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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Hannah Johnson 0203 437 6712
phoenix-icrctsu@icr.ac.uk


Study Location:

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Be Part of Research - Trial Details - PHOENIX DDR/Anti-PD-L1 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

PHOENIX DDR/Anti-PD-L1 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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Breast Neoplasms
Triple Negative Breast Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


PHOENIX is a window of opportunity (WOP), open-label, multi-centre, phase IIa trial comprising multiple non-comparative treatment cohorts with patient allocation via randomisation. The trial consists of two parts: a post-neoadjuvant chemotherapy, preoperative WOP component (PART 1); and a post-operative component (PART 2).

PHOENX aims to assess whether short exposure to a DNA damage response (DDR) inhibitor and/or anti-PD-L1 immunotherapy in a preoperative WOP in patients with post-NACT high residual disease, generates a signal of anti-tumour biological activity within residual disease tissue.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2019 Mar 2023

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : PART 1: Pre-operative exposure of 160mg AZD6738 to be administered orally twice daily on Days 5 -14 of the WOP.

PART 2: 12 months post-operative exposure to 160mg AZD6738 to be administered orally twice daily on Days 1 - 14 of a 28 day cycle.

Intervention Arm Group : Cohort B (AZD6738 monotherapy);

Intervention Type : DRUG
Intervention Description : PART 1: Pre-operative exposure to 300mg of olaparib to be administered orally twice daily on Days 1-14 of the WOP.

PART 2: 12 months post-operative exposure to 300mg olaparib (2 x 150mg tablets) to be administered orally twice daily on a continuous schedule Day 1-28 of a 28 day cycle.

Intervention Arm Group : Cohort C (olaparib monotherapy);

Intervention Type : DRUG
Intervention Description : PART 1: Pre-operative exposure to 1500mg durvalumab to be administered via intravenous (IV) infusion on Day 1 only of the WOP.

PART 2: 12 months post-operative exposure to 1500mg durvalumab to be administered via intravenous (IV) infusion on Day 1 only of a 28 day cycle.

Intervention Arm Group : Cohort D (durvalumab monotherapy);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guy's and St Thomas' Hospital NHS Foundation Trust
    London
    SE1 9RT
  • Christie Hospital NHS Trust
    Manchester
    England
    M20 4BX
  • Bristol Haematology and Oncology Centre
    Bristol
    England
    BS2 8ED
  • Belfast City Hospital
    Belfast
    Northern Ireland
    BT9 7AB
  • Weston Park Hospital
    Sheffield
  • Royal Bournemouth Hospital
    Bournemouth
    Dorset
    BH7 7DW
  • King's College Hospital
    London
    England
    SE5 9RS
  • Velindre Cancer Center at Velinde Hospital
    Cardiff
    Wales
    CF14 2TL
  • Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust
    Birmingham


The study is sponsored by Institute of Cancer Research, United Kingdom and is in collaboration with AstraZeneca.




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Read full details for Trial ID: NCT03740893
Last updated 19 February 2020

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