Breast Neoplasm Clinical Trial
Official title:
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 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.
n/a
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