Study of risk of chemo-induced peripheral neuropathy from taxane therapy in African American women with breast cancer

Study ID: EAZ171

Docetaxel or paclitaxel in reducing chemotherapy-induced peripheral in African American patients with stage I-III breast cancer

This phase 2 trial is studying how well the chemotherapies docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy (CIPN) in African American patients who have been diagnosed with stages I-III breast cancer. CIPN is a sensation of tingling, pain, numbness and/or weakness in the hands or feet. It is a common complication of various types of chemotherapies used to treat many cancers.

Additionally, peripheral neuropathy is one of the most important survivorship issues in all of the cancers, and African American women are markedly more likely to experience it, severely impacting both their quality of life and survival.

Participants in this clinical trial are grouped into two study arms:

  • Arm 1 receives paclitaxel intravenously once weekly. Treatment repeats every 21 days for 4 cycles. Patients may also receive other medications at the physician’s discretion.
  • Arm 2 receives docetaxel intravenously once every 3 weeks. Treatment repeats every 21 days. Patients may also receive other medications at the physician’s discretion.

In this non-randomized, phase II study, researchers seek to validate a prior germline predictor of paclitaxel-induced neuropathy.

Intervention/treatment:

  • Arm 1 patients receive paclitaxel 80mg/m2 weekly IV over 3 hours once weekly for 4 cycles. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician’s discretion.
  • Arm 2 patients receive docetaxel 75mg/m2 IV over 1 hour every 3 weeks. Treatment repeats for 4-6 cycles. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician's discretion.

Inclusion Snapshot

  • Women self-identified as African-American, Black or of African descent, and diagnosed with stage I–III breast cancer
  • Must have had no prior taxane therapy and no prior or concurrent platinum-based chemotherapy
  • Must have no pre-existing neuropathy

Contact Information

Lankenau Institute for Medical Research trial