Genetically Guided Epirubicin Dosing for Breast Cancer
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Epirubicin for breast cancer?
Epirubicin is shown to be effective in treating breast cancer, with studies reporting high response rates in patients with advanced breast cancer. In combination with other drugs, it has demonstrated significant activity, achieving overall response rates of up to 92% and complete response rates of 31% in some trials.12345
Is epirubicin generally safe for use in humans?
Epirubicin is generally considered safe for use in humans, with a lower risk of heart-related side effects compared to doxorubicin, another similar drug. Common side effects include hair loss, nausea, and low white blood cell counts, which can increase infection risk. Some patients may experience mild heart issues, especially at higher doses, but severe heart problems are less common.56789
What makes the drug Epirubicin unique for breast cancer treatment?
Epirubicin is unique because it is a less cardiotoxic (less harmful to the heart) and myelotoxic (less harmful to the bone marrow) alternative to doxorubicin, allowing for higher cumulative doses to be safely administered. Additionally, genetically guided dosing based on liver function can reduce variability in drug exposure, making treatment safer and more effective for patients with liver dysfunction.1251011
What is the purpose of this trial?
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.
Research Team
Michael B Sawyer, MD FRCPC BScPharm
Principal Investigator
Alberta Health services
John R Mackey, MD FRCPC
Principal Investigator
Alberta Health services
Eligibility Criteria
This trial is for women with non-metastatic invasive breast cancer, scheduled for specific chemo. They must have a good performance status, confirmed hormone receptor status, and a healthy heart function (LVEF ≥ 50%). It's not for those with recent heart attacks, uncontrolled heart conditions or severe psychiatric disorders.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Genetic Analysis
Participants undergo genetic analysis to determine epirubicin dosing
Treatment
Participants receive epirubicin dosing based on genetic profiles for cycles 2-4
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Epirubicin
Epirubicin is already approved in United States, European Union, Canada for the following indications:
- Breast cancer
- Breast cancer
- Ovarian cancer
- Soft tissue sarcoma
- Superficial bladder cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AHS Cancer Control Alberta
Lead Sponsor