OB/GYN & Women's Health
PHASE2
● Phase II
Study Validates Genotype Predictor of TIPN in African American Breast Cancer Patients
ClinicalTrials.gov
Published March 28, 2026
ECOG-ACRIN Cancer Research Group
NCT04001829 ↗
This phase II trial investigates the prospective validation of a germline predictor for taxane-induced peripheral neuropathy (TIPN) in African American patients with stage I-III breast cancer. The study enrolled 249 participants and is active but not recruiting. The primary objective is to validate a germline predictor of TIPN using the Common Terminology Criteria for Adverse Events (CTCAE), focusing on whether patients with a high-risk TIPN genotype experience more grade 2-4 TIPN compared to those with a low-risk genotype. Secondary objectives include validating the predictor using the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) subscale in Arm A, comparing grade 2-4 TIPN between weekly paclitaxel (Arm A) and every three-week docetaxel (Arm B), and confirming that dose reductions due to TIPN are lower with every three-week docetaxel compared to weekly paclitaxel. The study began on August 9, 2019, with primary completion on September 19, 2023, and results are expected to be posted by June 12, 2024. The lead sponsor is the ECOG-ACRIN Cancer Research Group.
AI Accuracy Review: 9/10
· Auto-published
If you or someone you know is facing breast cancer, understanding the side effects of treatment is crucial. This study focuses on African American patients with stages I-III breast cancer and explores how genetics can predict the risk of nerve pain caused by chemotherapy, known as taxane-induced peripheral neuropathy. By examining a specific genetic marker, the researchers aim to identify patients who may experience more severe nerve pain. They are also comparing two chemotherapy drugs: docetaxel and paclitaxel. The goal is to see if docetaxel leads to fewer cases of severe nerve pain compared to paclitaxel. This information is vital because it could help doctors choose the best treatment options for their patients, potentially reducing the risk of debilitating side effects. If you’re part of this community, knowing about these findings could empower you to discuss your treatment options more effectively with your healthcare provider.
What this means for you: Genetic testing may help identify breast cancer patients at risk for severe nerve pain from chemotherapy.
View Original Abstract ↓
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
