Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)

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)

Trial Details

NCT ID
NCT05215106
Phase
PHASE2
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Durvalumab
Locations (sample)
  • Bordeaux, France|44.84124,-0.58046
  • Lyon, France|45.74906,4.84789
  • Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

  • Patient should understand, sign, and date the written informed consent form (including the consent to collect tissue, blood and stool samples, as s…
  • Female patients aged 18 years or older
  • Histologically confirmed untreated invasive carcinoma of the breast (ER \< 10%, PR \< 10%, HER2 negative) as locally determined
  • Tumor infiltrating lymphocytes (TILs) ≥ 5% in breast tumor biopsy as locally determined

For full eligibility, visit ClinicalTrials.gov.

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