A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

AHS Cancer Control Alberta48 enrolled

Overview

Epirubicin is a common chemotherapy medication used in the treatment of breast cancer. However, chemotherapy dosing is calculated based on people's height and weight, which may not be the most accurate way. The purpose of this study is to see if epirubicin dosing based on people's genetic profiles is better than the usual methods.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Neoplasms

Interventions

EpirubicinDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female patients with histologically confirmed non-metastatic invasive breast cancer who are scheduled to receive at least three cycles of FEC100 in the adjuvant or neoadjuvant setting 2. Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor \[ER\], progesterone receptor \[PR\] and HER-2 status 3. Eastern Cooperative Oncology (ECOG) performance status of ≤ 2 4. A Left Ventricular Ejection Fraction (LVEF) ≥ 50%. Exclusion Criteria: 1. Uncontrolled congestive heart failure (CHF) or angina, history of myocardial infarction within 2 months before study enrollment, or cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification. 2. Psychiatric disorder(s) that would interfere with consent, study participation, or follow up.

Locations (1)

Cross Cancer Institute

Edmonton, Alberta, Canada

RECRUITING

Outcomes

Primary Outcomes

The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.

Primary Objectives To describe the side effects of pharmacogenetically individualized FEC chemotherapy in the adjuvant and neoadjuvant treatment of breast cancer.

Time frame: 10 years

Secondary Outcomes

Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics

Time frame: 10 years

Central Contacts

Denise Brown, RN MN

CONTACT

780-432-8956 denise.brown3@albertahealthservices.ca

Data from ClinicalTrials.gov

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