Trials / Active Not Recruiting

Active Not RecruitingNCT04001829

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

Prospective Validation Trial of Taxane Therapy (Docetaxel or Weekly Paclitaxel) and Risk of Chemotherapy-Induced Peripheral Neuropathy in African American Women

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 249 (actual)

Sponsor: ECOG-ACRIN Cancer Research Group · Network
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

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 cohort of patients of African ancestry. IV. Prospectively confirm dose reductions due to any cause are lower for every three-week docetaxel compared with weekly paclitaxel in a prospective cohort of patients of African ancestry. V. Assess the ability of the high-risk genotype to predict TIPN risk for docetaxel. EXPLORATORY OBJECTIVES: Correlative Study Objectives: I. Identify novel markers of TIPN and elucidate the mechanism. II. Whole genome sequencing of germline blood to evaluate for additional predictors of TIPN. III. Create induced pluripotent stem cell (iPSC) derived neurons from patient samples. IIIa. Evaluate whether clinical findings can be mimicked in vitro. IIIb. Evaluate gene expression (ribonucleic acid \[RNA\] sequencing \[seq\]) and the epigenome at baseline versus after exposure in those prone to TIPN versus those not. IV. Create a biorepository of patient derived samples for future translational research. Patient-Reported Outcome Objectives: I. Compare Grade 2-4 TIPN (moderate to life threatening) based on Patient Reported Outcomes (PRO)-CTCAE items between weekly paclitaxel (Arm A) vs. every three-week docetaxel (Arm B). II. Prospectively compare FACT/GOG-NTX Health-Related Quality of Life (HRQoL) subscale, Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function version (v.)2 Short Form (SF) 10a, scores between every three-week docetaxel and weekly paclitaxel and between high risk and low risk genotypes (Arm A) in a cohort of African ancestry. III. Compare the impact on financial toxicity (Comprehensive Score for Financial Toxicity \[COST\] scores) for every three-week docetaxel compared with weekly paclitaxel. IV. Examine associations between social determinants of health (zip code, marital status, education, income \& insurance status) and dose reductions and treatment discontinuation. OUTLINE: Patients are assigned to 1 of 2 arms. ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician?s discretion. ARM B: Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician?s discretion. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

Type	Name	Description
DRUG	Docetaxel	Given IV
DRUG	Paclitaxel	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2019-08-09
Primary completion: 2023-09-19
Completion: 2027-03-31
First posted: 2019-06-28
Last updated: 2026-03-13
Results posted: 2024-06-12

Locations

485 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04001829. Inclusion in this directory is not an endorsement.