Overview

Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer

Status:
Withdrawn

Trial end date:
2018-05-01

Target enrollment:

Participant gender:

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.

Phase:

Early Phase 1

Details

Lead Sponsor:

University of Virginia

Collaborator:

Celldex Therapeutics

Treatments:

Antibodies, Monoclonal
Cyclophosphamide
Doxorubicin
Glembatumumab vedotin
Liposomal doxorubicin