Clinical trial · Observational
This Study Investigates the Impact of Single Nucleotide Polymorphisms in Genes Involved in the Pharmacokinetics and Toxicity of Doxorubicin (DOX) in Egyptian Female Patients with Breast Cancer. It Also Aims to Explore the Association of Pretreatment Neutrophil to Lymphocyte Ratio to PCR
Effects of Pharmacogenetics on Pharmacokinetics and Toxicity of Doxorubicin in Egyptian Breast Cancer Patients
NCT06595758CI-TRIAL-00080543completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to investigate the effect of single nucleotide polymorphisms (SNPs) of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients. It also aims to explore the association of pretreatment neutrophil to lymphocyte ratio (NLR) with pathological complete response (pCR).
Conditions
Conditions (1)
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 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Doxorubicin plasma concentrations
- timeFrame
- baseline
- description
- Plasma concentrations of doxorubicin will be determined using a suitable analytical method.
- measure
- neutrophil to lymphocyte ratio
- timeFrame
- baseline
- description
- The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Females aged ≥ 18 years * Performance status 0 or 1 * No contraindication to chemotherapy * Adequate bone marrow * Adequate hepatic function * Adequate renal function Exclusion Criteria: * Poorly controlled diabetes mellitus * Ischemic heart disease * Uncontrolled hypertension * Active infections * Baseline ejection fraction \< 50% * Performance status ≥ 2 * Pregnancy Lactation, bilateral breast cancer, male patients, primary surgery, distant metastases, other malignancies, inflammations, hematological disorders, autoimmune diseases, and patients taking non-steroidal anti-inflammatory drugs (NSAIDs), steroidal and antibiotic therapy.
References
Publications (2)
- BACKGROUNDLal S, Wong ZW, Jada SR, Xiang X, Chen Shu X, Ang PC, Figg WD, Lee EJ, Chowbay B. Novel SLC22A16 polymorphisms and influence on doxorubicin pharmacokinetics in Asian breast cancer patients. Pharmacogenomics. 2007 Jun;8(6):567-75. doi: 10.2217/14622416.8.6.567. PMID 17559346
- BACKGROUNDSpeth PA, van Hoesel QG, Haanen C. Clinical pharmacokinetics of doxorubicin. Clin Pharmacokinet. 1988 Jul;15(1):15-31. doi: 10.2165/00003088-198815010-00002. PMID 3042244