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 with 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, 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 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 HIV due to concern that chemotherapy may cause further
immunosuppression and potential infectious complications.

- Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with
documented bleeding disorders will be excluded due to risk of bleeding with biopsy.

- 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 because paclitaxel is a pregnancy category
D drug and may cause deleterious effects to the fetus. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled
in the trial.