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Protocol No. UW16106

Principal Investigator Burkard, Mark

Phase N/A

Age Group Adult

Scope Local

Sponsor Type Institutional

Title Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

Objective The purpose of this study is to learn why some breast cancers respond to paclitaxel chemotherapy and others do not. This study is looking for scientific clues to see if an individual will respond to taxane therapy. The study is also trying to see if paclitaxel(taxane) levels can be measured in tumors and plasma after it is given and whether the drug levels can be linked with response to therapy. Receiving paclitaxel before surgery is used clinically at the University of Wisconsin and would be a treatment option whether or not you choose to participate in this study.

Treatment Participants will have an analysis of tumor tissue that is taken after paclitaxel chemotherapy is given and the tissue obtained from your original breast biopsy.

Description The day after your first paclitaxel treatment, you will have a blood draw and a biopsy of your tumor. The biopsy is a simple outpatient procedure done by your doctor. After completion of your paclitaxel chemotherapy you will have an ultrasound, a mammogram, an MRI or other test to measure your tumor as part of your routine cancer care. Your doctors will decide whether to do additional chemotherapy before or after you have your surgery to remove your tumor. Any additional treatment would be part of your standard clinical care, and would not be part of your study participation.

Key Eligibility
  • Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist
  • Patients must not have metastatic disease on staging work-up with chest imaging, CBC, and liver function studies.
  • Patients may not have had prior systemic chemotherapy or targeted therapy regimens administered for treatment of their current breast cancer
  • Patients must be willing to undergo additional biopsy of breast tumor
  • Patients who have had systemic chemotherapies, targeted therapies or radiotherapy for any cancer within 5 years prior to entering the study are excluded
  • Patients with documented bleeding disorders will be excluded
  • Patients with known HIV are excluded
  • 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

Applicable Disease Sites Breast

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved paclitaxel; taxol (paclitaxel)

Status Open

Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park