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