Back to resultsA Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients
Primary Purpose
Breast Neoplasms
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Epirubicin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring breast cancer, non-metastatic carcinoma of the breast chemotherapy, adjuvant therapy, neoadjuvant
Eligibility Criteria
Inclusion Criteria:
- 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
- Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER], progesterone receptor [PR] and HER-2 status
- Eastern Cooperative Oncology (ECOG) performance status of ≤ 2
- A Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
Exclusion Criteria:
- 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.
- Psychiatric disorder(s) that would interfere with consent, study participation, or follow up.
Sites / Locations
- Cross Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epirubicin
Arm Description
Following genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics
Full Information
NCT ID
NCT01740271
First Posted
November 16, 2012
Last Updated
October 1, 2014
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT01740271
Brief Title
A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients
Official Title
Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Recruiting
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
breast cancer, non-metastatic carcinoma of the breast chemotherapy, adjuvant therapy, neoadjuvant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epirubicin
Arm Type
Experimental
Arm Description
Following genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Primary Outcome Measure Information:
Title
The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.
Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER], progesterone receptor [PR] and HER-2 status
Eastern Cooperative Oncology (ECOG) performance status of ≤ 2
A Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
Exclusion Criteria:
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.
Psychiatric disorder(s) that would interfere with consent, study participation, or follow up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Brown, RN MN
Phone
780-432-8956
Email
denise.brown3@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Sawyer, MD FRCPC BScPharm
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John R Mackey, MD FRCPC
Organizational Affiliation
Alberta Health services
Official's Role
Study Director
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sawyer, MD
Phone
780-432-8248
12. IPD Sharing Statement
Learn more about this trial
A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients
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