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

Menoufia University100 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 \&lt; 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.

Outcomes

Primary Outcomes

Doxorubicin plasma concentrations

Plasma concentrations of doxorubicin will be determined using a suitable analytical method.

Time frame: baseline

neutrophil to lymphocyte ratio

The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes.