Ignite Creation Date:
2024-05-06 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03473691
Status:
WITHDRAWN
Last Update Posted:
2018-06-01
First Post:
2018-02-14
Brief Title:
Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Pilot Study of the Antibody-drug Conjugate Glembatumumab Vedotin CDX-011 Following Doxorubicin Adriamycin and Cytoxan as Neo-adjuvant Therapy in Glycoprotein NMB-expressing High Risk Triple Negative Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pharmaceutical company decided to withdraw funding and not provide drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Breast50
Brief Summary:
This is a single arm pilot study assessing safetyfeasibility 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 safetyfeasibility and secondary endpoints will be rates of pathologic complete response pCR and measurements of growth differentiation factor-11 GDF11 and glycoprotein NMB gpNMB expression
Detailed Description:
Patients will receive neo-adjuvant dose-dense DD doxorubicin Adriamycincyclophosphamide 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None