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Clinical Trial 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.


Clinical Trial Description

Patients will receive neo-adjuvant dose-dense (DD) doxorubicin (Adriamycin)/cyclophosphamide (AC) followed by GV. After completion of neo-adjuvant therapy, all patients will undergo lumpectomy (with radiation therapy) or mastectomy, and tissue will be assessed for residual disease to determine rates of pCR. Tumor tissue will be obtained by core needle biopsy and at the time of surgery for use in the correlative studies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03473691
Study type Interventional
Source University of Virginia
Contact
Status Withdrawn
Phase Early Phase 1
Start date May 1, 2018
Completion date May 1, 2018

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