Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
NCT04001829 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 249
Last updated 2026-05-15
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.
Conditions
- 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
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Invasive Breast Carcinoma
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
Interventions
- DRUG
-
Given IV
- DRUG
-
Given IV
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
ECOG-ACRIN Cancer Research Group
lead NETWORK
Principal Investigators
-
Bryan P Schneider · ECOG-ACRIN Cancer Research Group
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-09
- Primary Completion
- 2023-09-19
- Completion
- 2027-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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