Breast NeoplasmsPhase 2NCT01740271
A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients
A Phase 2 study testing Epirubicin in people with Breast Neoplasms, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Epirubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Michael Sawyer, MD, 780-432-8248
About this study
Official title: Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy
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.
- Conditions
- Breast Neoplasms
- Being tested
- Epirubicin
- Keywords
- breast cancer, non-metastatic carcinoma of the breast chemotherapy, adjuvant therapy, neoadjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
| Study group | Role | What they receive |
|---|---|---|
| Epirubicin | Experimental | Following genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4. Receives: Drug: Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael B Sawyer, MD FRCPC BScPharm, Principal investigator, Alberta Health servicesJohn R Mackey, MD FRCPC, Study director, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740271
- Sponsor's protocol ID
- FEC100-01
- Status last verified
- Oct 2014
- First submitted
- 16 Nov 2012
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy
- ClinicalTrials.gov ID
- NCT01740271
- Acronym / sponsor ID
- FEC100-01
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, non-metastatic carcinoma of the breast chemotherapy, adjuvant therapy, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epirubicin | Experimental | Drug: EpirubicinFollowing genetic analysis, depending on results, participants will receive either standard or increased epirubicin dosing for cycles 2 - 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epirubicin | Drug | Epirubicin |
Primary outcome
The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.
Time frame: 10 years
Primary Objectives To describe the side effects of pharmacogenetically individualized FEC chemotherapy in the adjuvant and neoadjuvant treatment of breast cancer.
1 secondary outcome
Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Sawyer, MD FRCPC BScPharm principal investigator
Alberta Health services
John R Mackey, MD FRCPC study director
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epirubicin in people with Breast Neoplasms, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Brown, RN MN (780-432-8956, denise.brown3@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.