Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™) Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer
This is a phase II one arm study. Patients with HER2(Human Epidermal Growth Factor Receptor
2) positive early stage breast cancer will receive ABI-007 and vinorelbine in combination
with trastuzumab before having breast surgery.
Approximately 50 patients will take part at multi-sites with potentially 20 patients
participating at the Emory Winship Cancer Institute, Grady Memorial Hospital, and Emory
Crawford Long Hospital in Atlanta, Georgia.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Complete Pathologic Response.
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR. Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response.
assess at 8 weeks
Ruth O'Regan, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|
|Piedmont Hospital Research Institute||Atlanta, Georgia 30309|