Defining an Exposure Target for Weekly Paclitaxel Infusion in Breast Cancer Patients

Completed

Conditions studied: Breast Cancer

In brief

The purpose of this prospective observational study is to understand the relationship between paclitaxel exposure and development of peripheral neuropathy during treatment.

Key facts

Study ID

NCT02338115

Run by

University of Michigan Rogel Cancer Center

People needed

60

Starts

2014-05-01

Expected to finish

2016-12-20

Last updated by the study team

2017-05-02

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of invasive breast cancer
• Systemic treatment with paclitaxel for curative intent (neoadjuvant, adjuvant, or oligometastatic disease per PI discretion)
• 80 mg/m2 1-hour infusions weekly for up to 12 weeks
• Female sex
• >18 years old
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if…

• Any prior or concurrent treatment with neurotoxic chemotherapy including any taxane, vinca alkaloid, platinum, bortezomib, or thalidomide. Note that concurrent biologic treatment with trastuzumab/pertuzumab for HER2+ patients or prior treatment with Adriamycin/cyclophosphamide are not reasons for exclusion.
• Distant metastatic disease
• Concurrent treatment with duloxetine or enrollment on clinical study of neuroprotective agent
• History of allergic reaction to paclitaxel or cremophor EL
• Current signs or symptoms of severe peripheral neuropathy
• Known family history of hereditary peripheral neuropathy or Charcot-Marie-Tooth disease
• Known current pregnancy

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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