Your session is about to expire
← Back to Search
Anti-tumor antibiotic
Genetically Guided Epirubicin Dosing for Breast Cancer
Phase 2
Recruiting
Led By Michael B Sawyer, MD FRCPC BScPharm
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology (ECOG) performance status of ≤ 2
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is testing whether using a person's genetic profile to calculate epirubicin dosage is more effective than the current method.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Epirubicin may cause side effects like hair loss, nausea, vomiting, mouth sores, low blood cell counts increasing infection risk; and potential heart damage which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most of my daily activities on my own.
Select...
I am a woman with breast cancer set to receive FEC100 treatment.
Select...
My breast cancer has been tested for hormone receptor status.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.
Secondary outcome measures
Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics
Side effects data
From 2021 Phase 3 trial • 1846 Patients • NCT0196647166%
Alopecia
66%
Nausea
66%
NAUSEA
66%
ALOPECIA
46%
FATIGUE
46%
Fatigue
44%
Diarrhoea
44%
DIARRHOEA
37%
Epistaxis
37%
EPISTAXIS
35%
Aspartate aminotransferase increased
35%
ASPARTATE AMINOTRANSFERASE INCREASED
33%
Constipation
33%
Alanine aminotransferase increased
33%
CONSTIPATION
33%
ALANINE AMINOTRANSFERASE INCREASED
32%
VOMITING
32%
Vomiting
29%
Headache
29%
HEADACHE
29%
Arthralgia
27%
Decreased appetite
27%
DECREASED APPETITE
26%
ARTHRALGIA
25%
STOMATITIS
25%
Stomatitis
25%
Pyrexia
25%
PYREXIA
24%
Neutropenia
24%
NEUTROPENIA
23%
RASH
23%
Rash
22%
RADIATION SKIN INJURY
22%
Radiation skin injury
21%
Peripheral sensory neuropathy
21%
PERIPHERAL SENSORY NEUROPATHY
19%
Anaemia
19%
Nasopharyngitis
19%
NASOPHARYNGITIS
19%
ANAEMIA
18%
Dysgeusia
18%
THROMBOCYTOPENIA
18%
Thrombocytopenia
17%
Myalgia
17%
Cough
17%
DYSGEUSIA
17%
COUGH
17%
Insomnia
17%
INSOMNIA
17%
MYALGIA
16%
Platelet count decreased
16%
PLATELET COUNT DECREASED
15%
NEUROPATHY PERIPHERAL
15%
Neuropathy peripheral
14%
INFUSION RELATED REACTION
14%
PRURITUS
14%
Upper respiratory tract infection
14%
ASTHENIA
14%
Pruritus
14%
Infusion related reaction
14%
Asthenia
14%
UPPER RESPIRATORY TRACT INFECTION
13%
Pain in extremity
13%
PAIN IN EXTREMITY
12%
MUCOSAL INFLAMMATION
12%
Dizziness
12%
DYSPEPSIA
12%
DIZZINESS
12%
Dry mouth
12%
Dyspepsia
12%
Mucosal inflammation
12%
DRY MOUTH
11%
PARAESTHESIA
11%
Muscle spasms
11%
DRY SKIN
11%
Oropharyngeal pain
11%
Dry skin
11%
Paraesthesia
11%
MUSCLE SPASMS
11%
OROPHARYNGEAL PAIN
11%
HOT FLUSH
11%
Hot flush
10%
ABDOMINAL PAIN UPPER
10%
BACK PAIN
10%
Abdominal pain upper
10%
Back pain
9%
Blood bilirubin increased
9%
Rhinorrhoea
9%
BLOOD BILIRUBIN INCREASED
9%
WEIGHT DECREASED
9%
Abdominal pain
9%
Blood alkaline phosphatase increased
9%
Weight decreased
9%
Dyspnoea
9%
ABDOMINAL PAIN
9%
RHINORRHOEA
9%
DYSPNOEA
9%
BLOOD ALKALINE PHOSPHATASE INCREASED
8%
Neutrophil count decreased
8%
NAIL DISCOLOURATION
8%
Dry eye
8%
Lacrimation increased
8%
Nail discolouration
8%
LACRIMATION INCREASED
8%
Erythema
8%
Oedema peripheral
8%
DRY EYE
8%
OEDEMA PERIPHERAL
8%
NEUTROPHIL COUNT DECREASED
8%
ERYTHEMA
7%
MALAISE
7%
INFLUENZA LIKE ILLNESS
7%
Chills
7%
Taste disorder
7%
HYPOKALAEMIA
7%
TASTE DISORDER
7%
Urinary tract infection
7%
Influenza like illness
7%
Malaise
7%
Hypokalaemia
7%
URINARY TRACT INFECTION
7%
HYPERTENSION
7%
CHILLS
7%
Hypertension
6%
LEUKOPENIA
6%
Leukopenia
6%
MUSCULOSKELETAL PAIN
6%
DEPRESSION
6%
DERMATITIS ACNEIFORM
6%
Gingival bleeding
6%
Bone pain
6%
Depression
6%
Breast pain
6%
Dermatitis acneiform
6%
GINGIVAL BLEEDING
6%
BONE PAIN
6%
BREAST PAIN
5%
Anxiety
5%
Nail disorder
5%
HAEMORRHOIDS
5%
VISION BLURRED
5%
Vision blurred
5%
RASH MACULO-PAPULAR
5%
Haemorrhoids
5%
Conjunctivitis
5%
Paronychia
5%
PARONYCHIA
5%
ANXIETY
5%
CONJUNCTIVITIS
5%
NAIL DISORDER
5%
Rash maculo-papular
4%
GASTROOESOPHAGEAL REFLUX DISEASE
4%
Gastrooesophageal reflux disease
3%
Ejection fraction decreased
3%
FEBRILE NEUTROPENIA
3%
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
3%
LYMPHOEDEMA
3%
Palmar-plantar erythrodysaesthesia syndrome
3%
Febrile neutropenia
3%
EJECTION FRACTION DECREASED
3%
Lymphoedema
1%
PNEUMONIA
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epirubicin
FDA approved
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,164 Total Patients Enrolled
13 Trials studying Breast Cancer
1,337 Patients Enrolled for Breast Cancer
Michael B Sawyer, MD FRCPC BScPharmPrincipal InvestigatorAlberta Health services
John R Mackey, MD FRCPCStudy DirectorAlberta Health services
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe heart issues like recent heart attacks or uncontrolled heart failure.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.Your heart is pumping blood normally.
Research Study Groups:
This trial has the following groups:- Group 1: Epirubicin
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions does Epirubicin help alleviate?
"Epirubicin is most commonly used for treatment of transurethral resection (tur). It can also be taken to treat various conditions like ovarian cancer, urinary bladder, non-small cell lung carcinoma (nsclc)."
Answered by AI
Are recruitment efforts ongoing for this research project?
"That is correct. The clinical trial in question, which was first advertised on December 1st 2012, is still recruiting patients. They are looking for a total of 48 individuals from a single location to participate."
Answered by AI
Is Epirubicin a novel medication or has it been studied before?
"Epirubicin is currently being trialled in 66 different studies. Of these, 26 are classified as Phase 3 trials. The majority of Epirubicin trials are based out of Wenzhou, Zhejiang; however, there are 2106 locations running research for this medication."
Answered by AI
How many people fit the qualifications to take part in this research?
"That is correct. The clinicaltrials.gov website has the latest information on this trial, which was originally posted on December 1st, 2012 and last updated on October 1st, 2014. Currently, 48 patients are needed for the study taking place at a single site."
Answered by AI
What is the level of risk associated with Epirubicin?
"Epirubicin is a Phase 2 trial medication, meaning that while there is some evidence safety, there is none to support its efficacy. Our team at Power has given it a score of 2 in terms of safety."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger