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A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740271
Recruitment Status : Recruiting
First Posted : December 4, 2012
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Epirubicin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy
Study Start Date : December 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Epirubicin
Following genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4.
 Drug: Epirubicin


Outcome Measures
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Primary Outcome Measures :
  1. The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype. [ Time Frame: 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 :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740271


Contacts
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Contact: Denise Brown, RN MN 780-432-8956 denise.brown3@albertahealthservices.ca

Locations
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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Michael Sawyer, MD    780-432-8248      
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
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Principal Investigator: Michael B Sawyer, MD FRCPC BScPharm Alberta Health services
Study Director: John R Mackey, MD FRCPC Alberta Health services
More Information
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01740271    
Other Study ID Numbers: FEC100-01
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: October 2014
Keywords provided by AHS Cancer Control Alberta:
breast cancer
non-metastatic carcinoma of the breast chemotherapy
adjuvant therapy
neoadjuvant
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
 Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action