A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

AHS Cancer Control Alberta

Status and phase: Enrolling; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Epirubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01740271

FEC100-01

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

48 participants in 1 patient group

Epirubicin

Experimental group

Description:

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

Treatment:

Drug: Epirubicin