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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Other
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.
Frequently asked questions
Is NCT03740893 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PARP inhibitor, anti-PD-1 therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 negative is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify