Paclitaxel before Surgery in Treating Patients with Breast Cancer

Inclusion Criteria

• Women with pathologically demonstrated breast cancer
• Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist; no other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel
• Patients must not have metastatic disease on staging work-up with blood cell count (CBC) and liver function studies
• A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor or lymph node; a minimum of 8 slides must be available
• The primary tumor or lymph node must be readily biopsied by surgery or radiology teams
• The primary tumor must be measurable by an imaging modality prior to treatment; this imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery; such imaging modalities may include ultrasound, computed tomography (CT), mammography, or magnetic resonance imaging (MRI); MRI will be the preferred imaging modality if available; all imaging will be performed per standard of care at the discretion of the treating physicians
• Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer; however, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not Food and Drug Administration (FDA) approved for the treatment of the patient’s current breast cancer, are permitted
• Patients must have adequate organ and marrow function as determined by the treating oncologist
• Patient must be willing to undergo additional biopsy of breast tumor or lymph node
• Patient must have the ability and willingness to sign a written informed consent document
• Women of childbearing potential (per University of Wisconsin Carbone Cancer Center [UWCCC] policy definition) must agree to use effective contraception as discussed with treating oncologist for the duration of the study

Exclusion Criteria

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in cremophor(R) EL (polyoxyethylated castor oil)
• Patients with known human immunodeficiency virus (HIV)
• Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is enrolled in the trial