At a glance
ClinicalIndex Comparison Record- ✓Female patients aged 18 years or older
- ✓Histologically confirmed untreated invasive carcinoma of the breast with ER <10%, PR <10%, HER2 negative
- ✓Tumor infiltrating lymphocytes (TILs) ≥5% in breast tumor biopsy
- ✓Breast cancer clinical TNM stage I (cT1N0)
- ✕TILs <5%
- ✕Any systemic therapy or radiotherapy for current breast cancer before study entry
- ✕Known hypersensitivity to durvalumab or any of its components
- ✕Prior allogeneic stem cell or solid organ transplantation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05215106Phase 2RecruitingMonitorUpdated 23mo ago · Completion was 1mo agoShort-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)
In Brief
A Phase 2 clinical trial evaluating Durvalumab for Early Small (cT1N0) Triple Negative Breast Cancer. Currently recruiting, targeting 200 participants across 3 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
Following preparation of durvalumab, the entire contents of the IV bag should be administered as an IV infusion over approximately 60 minutes (±5 minutes), using a 0.2μm in-line filter (or add-on filter).