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

August 17, 2018
FB-12, FACT-1
Breast Cancer
Alexander Hantel, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

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)

1 year or less

Accepting Participants
Interventional
II
Kathy Seymour, BSN
630-646-6075
630-646-6110
630-646-6072