A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Epirubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor [ER], progesterone receptor [PR] and HER-2 status Eastern Cooperative Oncology (ECOG) performance status of ≤ 2 A Left Ventricular Ejection Fraction (LVEF) ≥ 50%. Exclusion Criteria: 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. Psychiatric disorder(s) that would interfere with consent, study participation, or follow up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epirubicin<br>Following genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4. | Drug: Epirubicin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype. | Primary Objectives To describe the side effects of pharmacogenetically individualized FEC chemotherapy in the adjuvant and neoadjuvant treatment of breast cancer. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, non-metastatic carcinoma of the breast chemotherapy, adjuvant therapy, neoadjuvant