An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant ACT + Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER2 Signaling Transduction
Active Date:
August 17, 2018
Expire Date:
August 17, 2018
IRB Number:
FB-12, FACT-1
Condition/Disease:
Breast Cancer
Lead Researcher:
Alexander Hantel, MD
Location:
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst
Purpose:
The main purpose of this study is to look at the safety and effectiveness of the standard anti-HER2-targeted therapies, trastuzumab and pertuzumab, when given before surgery with the standard chemotherapy, paclitaxel, for subjects whose tumors were HER2-negative by standard tests but showed abnormal HER2 signaling activity based on the CELx HSF results. These results might predict whether or not this breast cancer type will respond to treatment with trastuzumab and pertuzumab.
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Time Commitment:
1 year or less
Status:
Accepting Participants
Current Trial Type:
Interventional
Phase:
II
Contact Name:
Kathy Seymour, BSN
Phone:
630-646-6075
Fax:
630-646-6110
Alternate Phone:
630-646-6072