Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

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