Clinical trial · Observational
ABCB1 SNPs as Predictors of PIPN
ABCB1 Single Nucleotide Polymorphism Genotypes as Predictors of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neuropathy;Peripheral | — | UNRESOLVED | — |
| Paclitaxel Adverse Reaction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Real-Time PCR | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Grade 2 or higher peripheral neuropathy
- timeFrame
- 12 weeks
- description
- Grade 2 or higher peripheral neuropathy evaluated by the National Cancer Institute Common Toxicity Criteria (version 5.0)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (9)
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- BACKGROUNDKimchi-Sarfaty C, Marple AH, Shinar S, Kimchi AM, Scavo D, Roma MI, Kim IW, Jones A, Arora M, Gribar J, Gurwitz D, Gottesman MM. Ethnicity-related polymorphisms and haplotypes in the human ABCB1 gene. Pharmacogenomics. 2007 Jan;8(1):29-39. doi: 10.2217/14622416.8.1.29. PMID 17187507
- BACKGROUNDRivera E, Cianfrocca M. Overview of neuropathy associated with taxanes for the treatment of metastatic breast cancer. Cancer Chemother Pharmacol. 2015 Apr;75(4):659-70. doi: 10.1007/s00280-014-2607-5. Epub 2015 Jan 18. PMID 25596818
- BACKGROUNDScripture CD, Figg WD, Sparreboom A. Peripheral neuropathy induced by paclitaxel: recent insights and future perspectives. Curr Neuropharmacol. 2006 Apr;4(2):165-72. doi: 10.2174/157015906776359568. PMID 18615126
- BACKGROUNDGao B, Russell A, Beesley J, Chen XQ, Healey S, Henderson M, Wong M, Emmanuel C, Galletta L, Johnatty SE, Bowtell D; Australian Ovarian Cancer Study Group; Haber M, Norris M, Harnett P, Chenevix-Trench G, Balleine RL, deFazio A. Paclitaxel sensitivity in relation to ABCB1 expression, efflux and single nucleotide polymorphisms in ovarian cancer. Sci Rep. 2014 May 9;4:4669. doi: 10.1038/srep04669. PMID 24810093
- BACKGROUNDSparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. Preclinical pharmacokinetics of paclitaxel and docetaxel. Anticancer Drugs. 1998 Jan;9(1):1-17. doi: 10.1097/00001813-199801000-00001. PMID 9491787
- BACKGROUNDWolking S, Schaeffeler E, Lerche H, Schwab M, Nies AT. Impact of Genetic Polymorphisms of ABCB1 (MDR1, P-Glycoprotein) on Drug Disposition and Potential Clinical Implications: Update of the Literature. Clin Pharmacokinet. 2015 Jul;54(7):709-35. doi: 10.1007/s40262-015-0267-1.