ABCB1 SNPs as Predictors of PIPN

ABCB1 Single Nucleotide Polymorphism Genotypes as Predictors of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05093023

Enrollment

Registered

2021-10-26

Start date

2018-03-01

Completion date

2020-01-31

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Neuropathy;Peripheral, Paclitaxel Adverse Reaction

Brief summary

The study aim is to determine the allele frequencies of 1236 G\>A and 3435 G\>A in ABCB1 and study their association with the incidence and severity of paclitaxel-induced peripheral neuropathy while adjusting for other baseline covariates in Egyptian patients. Additionally, the study aimed at fitting and validating logistic regression models with the aforementioned SNPs evaluated in additive, dominant, overdominant, and recessive genetic models and performing diagnostics for the best model in terms of internal validity.

Interventions

GENETICReal-Time PCR

Genomic DNA was extracted from 2 ml of venous blood. ABCB1 1236 G\>A and 3435 G\>A were genotyped using predesigned TaqMan SNP genotyping assays on a stepOne PCR instrument in accordance with the manufacturer's protocol.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Egyptian females ≥18 years of age. 2. Histologically confirmed Breast Cancer. 3. Receiving conventional neoadjuvant or adjuvant weekly paclitaxel. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Adequate organ reserves ((serum creatinine ≤1.5x upper normal limit (UNL), total bilirubin ≤1.5x UNL, absolute neutrophil count ≥1.5 x 10\^9/L, platelet count ≥100 x 10\^9/L, AST and ALT ≤3.0x UNL, and alkaline phosphatase ≤3.0x UNL). 6. No major neurological disease or symptoms prior to the start of paclitaxel therapy. 7. neither subjective nor objective evidence of metastatic disease.

Exclusion criteria

1. Pregnancy. 2. Patients with recurrent or metastatic (local or distant) breast cancer. 3. Neuropathic at the time of recruitment. 4. History of neuropathy prior to recruitment. 5. Previously exposed to taxanes or any other microtubule Inhibitors, or regimens including platinates. 6. Patients currently receiving dose-dense biweekly taxane-containing regimens.

Design outcomes

Primary

Measure	Time frame	Description
Grade 2 or higher peripheral neuropathy	12 weeks	Grade 2 or higher peripheral neuropathy evaluated by the National Cancer Institute Common Toxicity Criteria (version 5.0)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026