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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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe heart issues like recent heart attacks or uncontrolled heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.

Side effects data

From 2021 Phase 3 trial • 1846 Patients • NCT01966471
66%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
26,666 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

Epirubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT01740271 — Phase 2
Breast Cancer Research Study Groups: Epirubicin
Breast Cancer Clinical Trial 2023: Epirubicin Highlights & Side Effects. Trial Name: NCT01740271 — Phase 2
Epirubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01740271 — Phase 2
~4 spots leftby Dec 2025
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