A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

NCT01740271 | Unknown Phase 2 DMC

• 1 other identifier: FEC100-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (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

  10 years

Study Arms (1)

Epirubicin

EXPERIMENTAL

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

Drug: Epirubicin

Interventions

Epirubicin DRUG

Epirubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Michael B Sawyer, MD FRCPC BScPharm

  Alberta Health services

  PRINCIPAL INVESTIGATOR

• John R Mackey, MD FRCPC

  Alberta Health services

  STUDY DIRECTOR

Central Study Contacts

Denise Brown, RN MN

CONTACT

780-432-8956; denise.brown3@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: December 4, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2025
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

CA (1)