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.
Disease site: Breast cancer
Treatment modality: Immunotherapy, Systemic targeted therapy
Status: Open to recruitment
PHOENIX is a Window of Opportunity (WOP), open-label, multi-centre, phase IIa platform trial in patients with neoadjuvant chemotherapy (NACT) resistant residual triple negative breast cancer (TNBC).
The trial population will include 81 patients with early TNBC who are poor responders to NACT with significant residual disease, as defined by MRI, and for whom definitive complete surgical excision of disease is planned. Eligible patients will be allocated to one of 4 cohorts: a standard of care reference cohort, 2 DDR inhibitor treatment cohorts or an anti-PD-L1 immunotherapy treatment cohort. The primary objective of the trial is to assess whether short exposure to a DDR inhibitor and/or anti-PD-L1 immunotherapy in the pre-operative WOP changes the biology of the disease in patients with post-NACT high risk residual disease.
Patients who received treatment pre-operatively and who are found to be ctDNA positive following surgery will resume treatment for a further 12 months.
All patients, including those who are ctDNA positive and receive further treatment and those who are ctDNA negative, will be followed up every 3 months for a total of 24 months post-surgery.
Chief Investigator: Professor Andrew Tutt, The Institute of Cancer Research and Kings College London
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research
View PHOENIX on the National Institute for Health Research website: NIHR - Be Part Of Research
A lay summary in plain English is available from Cancer Research UK: To be confirmed
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