Expired Study
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New Brunswick, New Jersey 08901


Purpose:

The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.


Criteria:

Inclusion Criteria: - Females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast - Radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as radiation or surgery - Positive status for human epidermal growth factor receptor 2 - Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines - Karnofsky performance status of 70 to 100 - Life expectancy of at least 3 months Exclusion Criteria: - Prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine - Common Terminology Criteria Grade 2 or greater neuropathy - Inadequate hematologic, hepatic, or renal function - Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or known hypersensitivity or prior intolerance to fluoropyrimidine - Known or suspected dihydropyrimidine dehydrogenase deficiency - More than 3 prior chemotherapy regimens in the metastatic setting - Prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months


NCT ID:

NCT00634088


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb


Backup Contact:

N/A


Location Contact:

New Brunswick, New Jersey 08901
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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