Identifying genetic variants linked to nerve damage in breast cancer patients treated with paclitaxel
Exploratory Next Generation Sequencing to Identify Causative Variants for Taxane-Induced Peripheral Neuropathy From Breast Cancer Study E5103 Germline DNA Samples
This study is trying to find out if certain genetic factors make breast cancer patients more likely to experience nerve damage after receiving the chemotherapy drug paclitaxel.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 575 (estimated) |
| Sex | All |
| Sponsor | National Cancer Institute (NCI) NIH |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02610439 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on using whole exome sequencing to analyze germline DNA samples from patients with peripheral neuropathy who have received paclitaxel for breast cancer. The primary goal is to identify rare genetic variants that may increase the risk of developing peripheral neuropathy, particularly in patients of African and European descent. By examining previously collected DNA samples, researchers aim to uncover biomarkers that could help predict which patients are more susceptible to nerve damage from chemotherapy.
Who should consider this trial
Good fit: Ideal candidates include European American and African American patients who have experienced significant peripheral neuropathy during paclitaxel treatment.
Not a fit: Patients who did not develop peripheral neuropathy or those without available DNA samples will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and personalized treatment strategies for breast cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies utilizing genetic sequencing to identify biomarkers for chemotherapy-related side effects have shown promise, suggesting this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * European American patients with DNA available and designated case or control * African American patients with DNA available and designated case or control status * Patients who developed grade 2-4 for African American (AA) and grade 3-4 for European American (EA) peripheral neuropathy during their treatment with paclitaxel and who did not develop peripheral neuropathy following a full course of treatment with paclitaxel
Where this trial is running
Boston, Massachusetts
- Eastern Cooperative Oncology Group — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Bryan P Schneider — Eastern Cooperative Oncology Group
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.