Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

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 per institutional guidelines.
• •A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor (preferred) 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, CT, mammography, or MRI. MRI will be the preferred imaging modality if available because it has the highest accuracy and positive predictive value for predicting pathologic complete response.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 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 institutional policy) must agree to use effective contraception as discussed with treating oncologist for the duration of the study.