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

• Status: Completed
• Trial end date: 2016-12-20
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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