48 Participants Needed

Genetically Guided Epirubicin Dosing for Breast Cancer

DB
Overseen ByDenise Brown, RN MN
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: AHS Cancer Control Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

MB

Michael B Sawyer, MD FRCPC BScPharm

Principal Investigator

Alberta Health services

JR

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

I can do most of my daily activities on my own.
I am a woman with breast cancer set to receive FEC100 treatment.
My breast cancer has been tested for hormone receptor status.
See 1 more

Exclusion Criteria

I do not have severe heart issues like recent heart attacks or uncontrolled heart failure.
Psychiatric disorder(s) that would interfere with consent, study participation, or follow up

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Analysis

Participants undergo genetic analysis to determine epirubicin dosing

1-2 weeks

Treatment

Participants receive epirubicin dosing based on genetic profiles for cycles 2-4

6-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Treatment Details

Interventions

  • Epirubicin
Trial Overview The study tests if dosing the chemotherapy drug Epirubicin based on genetic profiles leads to better outcomes than the standard method of dosing by height and weight in breast cancer treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EpirubicinExperimental Treatment1 Intervention
Following genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4.

Epirubicin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Ellence for:
  • Breast cancer
🇪🇺
Approved in European Union as Pharmorubicin for:
  • Breast cancer
  • Ovarian cancer
  • Soft tissue sarcoma
  • Superficial bladder cancer
🇨🇦
Approved in Canada as Epirubicin for:
  • Breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials
188
Recruited
26,900+

Findings from Research

A comprehensive physiologically based pharmacokinetic (PBPK) model was developed to simulate epirubicin exposure in a cohort of 2000 cancer patients, revealing that individual differences in drug metabolism significantly affect plasma concentrations of epirubicin.
Key factors influencing variability in epirubicin exposure included hepatic and renal UGT2B7 expression, plasma albumin levels, age, body surface area (BSA), glomerular filtration rate (GFR), hematocrit, and sex, explaining 87% of the variability in drug exposure.
A Physiologically Based Pharmacokinetic Model to Predict Determinants of Variability in Epirubicin Exposure and Tissue Distribution.Ansaar, R., Meech, R., Rowland, A.[2023]
In a study of 64 patients with locally advanced or metastatic breast cancer, a combination treatment including epirubicin allowed for dose escalation up to 120 mg/m², leading to a high overall response rate of 72% in metastatic cases, with a 25% complete response rate.
The use of granulocyte colony-stimulating factor (G-CSF) helped prevent neutropenia, but the treatment was associated with significant cumulative bone marrow toxicity, highlighting the need for careful monitoring of blood cell counts during therapy.
Laevofolinic acid, 5-fluorouracil, cyclophosphamide and escalating doses of epirubicin with granulocyte colony-stimulating factor support in locally advanced and/or metastatic breast carcinoma: a phase I-II study of the Southern Italy Oncology Group (GOIM).Colucci, G., Romito, S., Gebbia, V., et al.[2019]
Epirubicin demonstrated a 44% overall response rate in 61 patients with advanced soft tissue sarcoma, with higher response rates observed at increased doses (17% at 140 mg/m², 44% at 160 mg/m², and 100% at 180 mg/m²).
The maximum-tolerated dose was determined to be 180 mg/m², but the recommended clinical dose is 160 mg/m² every 3 weeks, as it was safe and effective while minimizing severe side effects like myelosuppression.
Increasing single epirubicin doses in advanced soft tissue sarcomas.Lopez, M., Vici, P., Di Lauro, L., et al.[2017]

References

A Physiologically Based Pharmacokinetic Model to Predict Determinants of Variability in Epirubicin Exposure and Tissue Distribution. [2023]
Laevofolinic acid, 5-fluorouracil, cyclophosphamide and escalating doses of epirubicin with granulocyte colony-stimulating factor support in locally advanced and/or metastatic breast carcinoma: a phase I-II study of the Southern Italy Oncology Group (GOIM). [2019]
Increasing single epirubicin doses in advanced soft tissue sarcomas. [2017]
Epirubicin. An updated review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in the management of breast cancer. [2018]
Role of epirubicin in advanced breast cancer. [2019]
Phase I trial of adjuvant chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil (CEF) for stage II breast cancer. [2019]
Epirubicin high-dose therapy in advanced breast cancer: preliminary clinical data. Epirubicin as a single agent in breast cancer. [2013]
Single agent epirubicin as first line chemotherapy for metastatic breast cancer patients. [2019]
Epirubicin has modest single-agent activity in head and neck cancer but limited activity in metastatic melanoma and colorectal cancer: phase II studies by the Eastern Cooperative Oncology Group. [2019]
Epirubicin in patients with liver dysfunction: development and evaluation of a novel dose modification scheme. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
A phase II trial of epirubicin plus paclitaxel in metastatic breast cancer. United Kingdom Coordinating Committee for Cancer Research Breast Cancer Sub-Committee. [2015]
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