OncoMatch/Clinical Trials/NCT03740893
PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition With or Without Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Treatment Resistant Residual Triple Negative Breast Cancer
Is NCT03740893 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AZD6738 and Olaparib for breast neoplasm.
Treatment: AZD6738 · Olaparib · Durvalumab — PHOENIX is a window of opportunity (WOP), open-label, multi-centre, phase IIa trial comprising multiple non-comparative treatment cohorts with patient allocation via minimisation (cohorts A-D) or allocation according to HRD and germline BRCA1/2 mutation status (cohorts E-G). The trial consists of two parts: a post-neoadjuvant treatment preoperative WOP component (PART 1); and a post-operative component (PART 2). Cohorts A-D: To assess whether short exposure to a DDR inhibitor or anti-PD-L1 immunotherapy in a preoperative WOP in patients with post-NACT high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue. Cohort E: To assess whether short exposure to a DDR inhibitor with or without anti-PD-1 immunotherapy in a preoperative WOP in patients with non-HRD associated TNBC and post-neoadjuvant treatment high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue. Cohorts F \& G: To assess whether short exposure to the DDR inhibitor olaparib with or without anti-PD-1 immunotherapy in a preoperative WOP in patients with HRD associated TNBC and post-neoadjuvant treatment high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative (immunohistochemistry 0/1+ or negative in situ hybridization)
Required: ESR1 negative (allred score 0/8, 1/8 or 2/8 or stain in <1% of cancer cells)
Required: PR (PGR) negative (allred score 0/8, 1/8 or 2/8 or stain in <1% of cancer cells)
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
at least 6 cycles of neoadjuvant chemotherapy (NACT)
Cannot have received: PARP inhibitor (olaparib)
Prior exposure to PARP inhibitor, including olaparib
Cannot have received: anti-PD-1 therapy
Exception: except for pembrolizumab if received as standard of care in combination with neoadjuvant chemotherapy
Prior exposure to anti-PD-1 or anti-PDL1 immunotherapy (including durvalumab) except for pembrolizumab if received as standard of care in combination with neoadjuvant chemotherapy
Lab requirements
Blood counts
Haemoglobin ≥ 10 g/dL with no blood transfusion in the past 28 days; ANC ≥ 1500/mm3; Platelet count ≥100,000/mm3
Kidney function
Calculated creatinine clearance ≥51 mL/min
Liver function
Total bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 2.5 x institutional ULN
Cardiac function
No uncontrolled, potentially irreversible cardiac conditions (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >470 msec, electrolyte disturbances, etc.), or congenital long QT syndrome
Patients must have adequate haematological, renal and hepatic function as defined by: Haemoglobin (Hb) ≥ 10 g/dL (≥ 100 g/L) with no blood transfusion in the past 28 days; Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 x 109/L); Platelet count ≥100,000/mm3 (≥ 100 x 109/L); Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); AST/ALT ≤ 2.5 x institutional ULN; Calculated creatinine clearance ≥51 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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