Study Validates Genotype Predictor of TIPN in African American Breast Cancer Patients

Status: ACTIVE_NOT_RECRUITING | Phase: PHASE2 Condition(s): Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8 Intervention(s): Docetaxel (DRUG), Paclitaxel (DRUG), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER) 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. Detailed: PRIMARY OBJECTIVES: I. Prospectively validate a prior germline predictor of TIPN using the Common Terminology Criteria for Adverse Events (CTCAE). Specifically, this study will demonstrate that patients with a high-risk TIPN genotype have significantly more grade 2-4 TIPN than patients with a low risk genotype. SECONDARY OBJECTIVES: I. Validate a prior germline predictor of TIPN using the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) neurotoxicity subscale in Arm A. II. Compare grade 2-4 TIPN based on CTCAE between weekly paclitaxel (Arm A) versus (vs.) every three-week docetaxel (Arm B). III. Prospectively confirm dose reductions due to TIPN are lower for every three-week docetaxel compared with weekly paclitaxel in a prospective Primary Outcome(s): Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A Enrollment: 249 (ACTUAL) Lead Sponsor: ECOG-ACRIN Cancer Research Group Start: 2019-08-09 | Primary Completion: 2023-09-19 Results posted: 2024-06-12