Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer

Phase 2 Active not recruiting 249 enrolled ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI) · collab

Non-randomizedParallel-groupOpen-labelSupportive care

Summary

This phase II trial studies whether a prior germline predictor of taxane-induced peripheral neuropathy (TIPN) can help identify a subgroup of patients who are at higher risk of chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. The study also investigates whether docetaxel maybe work better than paclitaxel with regard to TIPN rate/severity and dose reductions.

Timeline

Start: 2019-08-09
Primary completion: 2023-09-19
Completion: 2027-03-31

Outcome

Missed primary endpoint

paper Physician-reported grade 2-4 TIPN was not significantly different in high- versus low-risk genotype groups with once weekly paclitaxel (47% v 35%; P = .27) PMID 38828938 ↗

Publications

Schneider BP, Zhao F, Ballinger TJ, Garcia SF, Shen F, Virani S, Cella D, Bales C, Jiang G, Hayes L, Miller N, Srinivasiah J, Stringer-Reasor EM, Chitalia A, Davis AA, Makower DF, Incorvati J, Simon MA, Mitchell EP, DeMichele A, Miller KD, Sparano JA, Wagner LI, Wolff AC. ECOG-ACRIN EAZ171: Prospective Validation Trial of Germline Predictors of Taxane-Induced Peripheral Neuropathy in Black Women With Early-Stage Breast Cancer. J Clin Oncol. 2024 Aug 20;42(24):2899-2907. doi: 10.1200/JCO.24.00526. Epub 2024 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	—	Intravenous
Subject	Paclitaxel	Small molecule	—	Intravenous