Spots Global Cancer Trial Database for Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

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Trial Identification

Brief Title: Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

Official Title: Pilot Neoadjuvant Trial in Breast Cancer With Combination of ABI-007 (Abraxane) and GW572016 (Lapatinib)

Study ID: NCT00331630

Conditions

Breast Cancer

Interventions

lapatinib ditosylate

paclitaxel albumin-stabilized nanoparticle formulation

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane together with lapatinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I, stage II, or stage III breast cancer.

Detailed Description: OBJECTIVES: Primary * 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. Secondary * 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 patients. * 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 patients. * 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 studies. PROJECTED ACCRUAL: A total of 30 patients will be accrued to this study.