Recruiting
Phase 2

Epirubicin

Sponsor:

AHS Cancer Control Alberta

Code:

NCT01740271

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Epirubicin

Study Details

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

Study ID

NCT01740271

Start date

Dec, 2012

Status verified date

Oct, 2014

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Epirubicin

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

Interventions

Epirubicin

Primary outcome measure

  • The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype. [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Denise Brown, RN MN

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

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Michael Sawyer, MD

780-432-8248

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Oct 2, 2014

Last verified

Oct, 2014

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2014-10-02.