A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

Phase 2

Recruiting

• Conditions: Breast Neoplasms
• Interventions: Drug: Epirubicin

• Registration Number: NCT01740271
• Lead Sponsor: AHS Cancer Control Alberta

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-30
• Study Start: 2012-12
• Study First Posted: 2012-12-04
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-01
• Last Update Posted: 2014-10-02
• Primary Completion: 2015-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epirubicin	Epirubicin	Following genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada