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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT06595758
• Lead Sponsor: Menoufia University

Brief Summary

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).

Detailed Description

Plasma concentrations of doxorubicin will be determined and venous blood samples will be obtained from each patient for SNP genotyping of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients \[prospective study\].

A complete blood count was carried out at baseline for patients receiving neoadjuvant chemotherapy. The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes \[ retrospective study\].

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-11-01
• Status Verified: 2023-09
• Study Completion: 2023-11-01
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Doxorubicin plasma concentrations	baseline	Plasma concentrations of doxorubicin will be determined using a suitable analytical method.
neutrophil to lymphocyte ratio	baseline	The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes.

Trial Locations

Locations (1)

Menofia university; 🇪🇬 Shibīn Al Kawm, Egypt