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Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy

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.

Type of Study:


Study Design:

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

Outcome Measure:

The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.

Outcome Description:

Primary Objectives To describe the side effects of pharmacogenetically individualized FEC chemotherapy in the adjuvant and neoadjuvant treatment of breast cancer.

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Michael B Sawyer, MD FRCPC BScPharm

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services


Canada: Health Canada

Study ID:




Start Date:

December 2012

Completion Date:

June 2025

Related Keywords:

  • Breast Neoplasms
  • breast cancer
  • non-metastatic carcinoma of the breast chemotherapy
  • adjuvant therapy
  • neoadjuvant
  • Breast Neoplasms
  • Neoplasms