Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Condition: Breast Neoplasm Female
MeSH terms: Breast Neoplasms
Intervention: Paclitaxel
Intervention description: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
Intervention MeSH terms: Paclitaxel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN)
      in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be
      administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on
      days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles
      2-4 prior to surgery.
    

Eligibility criteria:

        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.