Pilot Neoadjuvant Trial in Breast Cancer With Combination of ABI-007 (Abraxane) and GW572016 (Lapatinib)
- Determine the clinical response rate, as measured by clinical exam and imaging studies,
in patients with stage I-III breast cancer treated with neoadjuvant Abraxane in
combination with lapatinib.
- Determine the pathologic complete response rate in patients treated with this regimen.
- Correlate proliferation (Ki67), apoptosis (cleaved caspase-3), and angiogenesis (vW,
CD34) markers, measured before and after treatment, with tumor response in these
- Conduct other correlative studies, including epidermal growth factor receptor (EGFR),
HER2/neu, matrix metalloproteinases (MMPs), and transforming growth factor (TGF-β),
before and after treatment with this regimen to assess tumor response in these
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a pilot study. Patients are assigned to 1 of 2 treatment groups.
- Group 1: The first 10 patients receive Abraxane IV over 30 minutes on day 1 and oral
lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.
- Group 2: The next 20 patients receive Abraxane and lapatinib (at a higher dose) as in
group 1. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
Patients undergo blood collection and tumor biopsies periodically for correlative biomarker
PROJECTED ACCRUAL: A total of 30 patients will be accrued to this study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response rate as measured by clinical exam and imaging studies
Clinical response rate will be assessed by a clinical exam done at baseline, then before each study treatment cycle begins and a mammogram/ultrasound done at baseline, then after 4 cycles of study treatment (1 cyle = 21 days)
At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)
Virginia G. Kaklamani, MD
United States: Food and Drug Administration
|Joe Arrington Cancer Research and Treatment Center||Lubbock, Texas 79410-1894|
|Midwest Center for Hematology/Oncology||Joliet, Illinois 60432|
|Hematology-Oncology Associates of Illinois||Chicago, Illinois 60611-2998|
|Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields||Olympia Fields, Illinois 60461|
|Northwestern University, Northwestern Medical Faculty Foundation||Chicago, Illinois 60611-3013|