drugset / Trial / NCT03473691
Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm, pilot study assessing safety/feasibility and efficacy of neo-adjuvant glembatumumab vedotin (GV) in patients with high risk triple negative breast cancer (TNBC) with glycoprotein-NMB (gpNMB) expression ≥ 25%. Primary endpoints will be safety/feasibility, and secondary endpoints will be rates of pathologic complete response (pCR), and measurements of growth differentiation factor-11 (GDF11) and glycoprotein NMB (gpNMB) expression.
Timeline
- Start
- 2018-05-01
- Primary completion
- 2018-05-01
- Completion
- 2018-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glembatumumab Vedotin | Other / unclassified | 1.9 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |