Genetic-based chemotherapy dosing for breast cancer patients
Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy
This study is testing if giving breast cancer patients the chemotherapy drug epirubicin based on their genetic makeup works better than the usual method that uses height and weight.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | AHS Cancer Control Alberta Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT01740271 on ClinicalTrials.gov |
What this trial studies
This study investigates whether dosing the chemotherapy drug epirubicin based on genetic profiles is more effective than traditional methods that rely on height and weight. Female patients with non-metastatic invasive breast cancer who are set to receive at least three cycles of chemotherapy will be enrolled. The study aims to improve treatment outcomes by personalizing chemotherapy dosing, potentially leading to better efficacy and reduced side effects. Participants will be monitored for their response to the treatment and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are female patients with histologically confirmed non-metastatic invasive breast cancer scheduled for chemotherapy.
Not a fit: Patients with uncontrolled heart conditions or psychiatric disorders that interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized chemotherapy treatments for breast cancer patients.
How similar studies have performed: Other studies have shown promise in using genetic profiling for personalized medicine, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edmonton, Alberta
- Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Michael B Sawyer, MD FRCPC BScPharm — Alberta Health services
- Study coordinator: Denise Brown, RN MN
- Email: denise.brown3@albertahealthservices.ca
- Phone: 780-432-8956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.