drugset / Trial / NCT07102940
Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.
Timeline
- Start
- 2026-09-01
- Primary completion
- 2028-08
- Completion
- 2028-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eftilagimod Alfa | Protein / enzyme biologic | 30 mg | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Background | Paclitaxel | Small molecule | — | — |