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Trial Title:
A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients
NCT ID:
NCT01740271
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Epirubicin
Conditions: Keywords:
breast cancer
non-metastatic carcinoma of the breast chemotherapy
adjuvant therapy
neoadjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Epirubicin
Arm group label:
Epirubicin
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Michael Sawyer, MD
Phone:
780-432-8248
Start date:
December 2012
Completion date:
June 2025
Lead sponsor:
Agency:
AHS Cancer Control Alberta
Agency class:
Other
Source:
AHS Cancer Control Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01740271
