Details - Clinical Research

Clinical Research Details

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Descriptive Information

Title

Role of genetic polymorphisms of drug metabolizing enzymes and drug transporters in the risk and treatment of breast cancer

Investigator Name

Nathalie Khoueiry-Zgheib

nk16@aub.edu.lb

Protocol Id

N/A

Status

Completed- Has Results

Study Type

Observational A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

Phase

Looking for Med Students Volunteers

Conditions and Keywords

Conditions

Breast cancer

Keywords

Breast cancer, pharmacogenetics

Study Design

Primary Purpose

Basic / Translational

Classification

Safety and/or Efficacy Study

Time Perspective

Observational Study

Masking

N/A: Not Applicable

Intervention Model

N/A: Not Applicable

Allocation

N/A: Not Applicable

Observational Study Model

Cohort

Eligibility and IRB

Gender

Female

Age Limits

Min:

Max:

IRB Approval

Yes

Healthy Volunteer

Study Description

This is a cohort of 300 breast cancer patients who were recruited while they were receiving cytotoxic therapy at AUBMC between 2009 and 2012. The plan was to build a data set coupled with DNA for pharmacogenetics studies. So far 2 manuscripts have been published:

Manuscript 1: Haroun F, Al-Shaar L, Habib RH, El-Saghir N, Tfayli A, Bazarbachi A, Salem Z, Shamseddine A, Taher A, Cascorbi I, Zgheib NK. Effects of CYP2B6 genetic polymorphisms in patients receiving cyclophosphamide combination chemotherapy for breast cancer. Cancer Chemother Pharmacol. 2015 Jan;75(1):207-14. (PMID: 25428516)

This included an analysis of a sub-cohort of 145 breast cancer patients who received cyclophosphamide combination therapy and who were genotyped for CYP2B6. We have shown that CYP2B6 *5/*6, *6/*9 or *6/*6 haplotypes were associated with a significantly shorter time to recurrence of the disease. There were however no significant associations with myelo-toxicity.

Manuscript 2: Awada Z, Haider S, Tfayli A, Bazarbachi A, El-Saghir NS, Salem Z, Shamseddine A, Taher A, Zgheib NK. Pharmacogenomics variation in drug metabolizing enzymes and transporters in relation to docetaxel toxicity in Lebanese breast cancer patients: paving the way for OMICs in low and middle income countries.OMICS. 2013 Jul;17(7):353-67 (PMID: 23758476)

This included an analysis of a sub-cohort of 32 breast cancer patients: 18 who developed febrile neutropenia following docetaxel therapy (cases). They were age- and treatment- matched with 18 patients who did not develop febrile neutropenia on docetaxel (controls). They were all genotyped using the DMETPLus array from Affymetrix. We found that 12 SNPs in seven genes (ABCC6, ABCG1, ABCG2, CYP1A2, CYP2D6, FMO2 and FMO3) were significantly associated with febrile neutropenia after docetaxel treatment.

Population Description

This is a retrospective cohort of women with breast cancer who received all cycles of chemotherapy at the American University of Beirut Medical Center (AUBMC) between 2009 and 2011.

Sampling Method

Physician referrals of patients who approved to be consented for the study.

Inclusion Criteria

Adults (age more than 18 years) treated for breast cancer at AUBMC.

Exclusion Criteria

Refusal of consent.

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