Prospective Validation Trial of Taxane Therapy (Docetaxel or Weekly Paclitaxel) and Risk of Chemotherapy-Induced Peripheral Neuropathy in African American Women

Purpose

This phase II trial studies how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. Drugs used in chemotherapy, such as docetaxel and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving docetaxel or paclitaxel may work better than other methods in reducing chemotherapy-induced peripheral neuropathy in patients with breast cancer.

Eligibility

Ages: 18 and older
Sexes: Female
Accepts healthy volunteers?: No

For additional eligibility criteria, please contact the study team.

Procedures

Patients are assigned to 1 of 2 arms.

ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician's discretion.
ARM B: Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician?s discretion.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Contact the study team

Additional eligibility criteria and study procedure details can be explained by the study team. Please call or email:

Brandi Lattinville
Phone: 352.265.0680 ext. 87665
Email: blattinville@ufl.edu

Age

18 to 65
65 and over

Gender

Female

Keywords

Breast cancer, Peripheral neuropathy

Principal Investigator

Karen Weinstein, DO

Department

Oncology

Contact Information

blattinville@ufl.edu

352.265.0680 ext. 87665


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