A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title:

Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01740271
• Other study ID #: FEC100-01
• Status: Recruiting
• Phase: Phase 2
• First received: November 16, 2012
• Last updated: October 1, 2014
• Start date: December 2012
• Est. completion date: June 2025

Study information

• Verified date: October 2014
• Source: AHS Cancer Control Alberta
• Contact: Denise Brown, RN MN
• Phone: 780-432-8956
• Email: denise.brown3[@]albertahealthservices.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2025
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Epirubicin

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years	Yes
Secondary	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	Yes