OncoMatch/Clinical Trials/NCT05215106
Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)
Is NCT05215106 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Durvalumab for early small (ct1n0) triple negative breast cancer.
Treatment: Durvalumab — This study aims to evaluate the efficacy and safety of preoperative Durvalumab in patients with early small (cT1N0) triple negative breast cancer tumors. This study will recruit patients with early HR-negative breast cancer all invasive types (ER \< 10%, PR \< 10%, HER2 negative) and TILs \>=5%, eligible for a short-term treatment with Durvalumab. A total of 200 patients are planned to be enrolled in the study and which will receive 2 administrations of durvalumab 10mg/kg. After study treatment, patients: * In whom surgery is the first standard treatment strategy (i.e. after study treatment) no biopsy is required at the end-of-treatment visit. * In whom neo adjuvant therapy is the first standard treatment strategy (i.e. after study treatment) a breast ultrasound guided biopsy is mandatory at the EoT visit. If the biopsy-proven residual disease is demonstrated, patients will have the option to receive standard neoadjuvant therapy at the discretion of the treating investigator. Those with a complete response may proceed directly to surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression < 10% (< 10%)
ER < 10%
Required: PR (PGR) expression < 10% (< 10%)
PR < 10%
Required: HER2 (ERBB2) negative (negative)
HER2 negative
Disease stage
Required: Stage I
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Any systemic therapy (e.g, chemotherapy, targeted therapy, immune-therapy) or radiotherapy for current breast cancer disease before study entry
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hb > 9 g/dL, Serum albumin > 2.5 g/dL
Kidney function
Creatinine ≤ 1.5 x ULN
Liver function
Bilirubin ≤ 1.5 x ULN, AST or ALT < 3 x ULN, ALP < 2.5 x ULN (patients with known Gilbert disease who have serum bilirubin level ≤ 3 × the institutional ULN may be enrolled)
Cardiac function
LVEF < 50% excluded; history of significant cardiac disease/events within 12 months excluded; see exclusion criteria for details
Blood tests demonstrating: Creatinine ≤ 1.5 x ULN Bilirubin ≤ 1.5 x ULN, AST or ALT < 3 x ULN, ALP < 2.5 x ULN ... ANC ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hb > 9 g/dL, Serum albumin > 2.5 g/dL ... LVEF < 50% as determined by MUGA or ECHO excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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