A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01740271

Enrollment

Registered

2012-12-04

Start date

2012-12-31

Completion date

2025-06-30

Last updated

2014-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

breast cancer, non-metastatic carcinoma of the breast chemotherapy, adjuvant therapy, neoadjuvant

Brief summary

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.

Interventions

DRUGEpirubicin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.	10 years	Primary Objectives To describe the side effects of pharmacogenetically individualized FEC chemotherapy in the adjuvant and neoadjuvant treatment of breast cancer.

Secondary

Measure	Time frame
Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics	10 years

Countries

Canada

Contacts

Primary ContactDenise Brown, RN MN

denise.brown3@albertahealthservices.ca780-432-8956

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026