- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002953
Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer
A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Compare the activity and toxicity of epirubicin and cyclophosphamide with that of epirubicin and paclitaxel in patients with metastatic breast cancer.
OUTLINE: Patients are randomized to receive either epirubicin and cyclophosphamide or epirubicin and paclitaxel. Each drug combination is given every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Cape Town, South Africa, 7925
- Groote Schuur Hospital, Cape Town
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Preston, United Kingdom, PR2 9HT
- Royal Preston Hospital
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England
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Birmingham, England, United Kingdom, B15 2TT
- University Birmingham
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Bristol, England, United Kingdom, BS2 8ED
- Bristol Oncology Centre
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Bristol, England, United Kingdom, BS2 8BJ
- Bristol Royal Hospital for Sick Children
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Derby, England, United Kingdom, DE1 2QY
- Derbyshire Royal Infirmary
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Leeds, England, United Kingdom, LS16 6QB
- Cookridge Hospital
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Leicester, England, United Kingdom, LE1 5WW
- University Hospitals of Leicester
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London, England, United Kingdom, W1N 8AA
- Middlesex Hospital- Meyerstein Institute
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Merseyside, England, United Kingdom, L63 4JY
- Clatterbridge Centre for Oncology NHS Trust
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Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
- Newcastle General Hospital
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Northwood, England, United Kingdom, HA6 2RN
- Mount Vernon Hospital
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Norwich, England, United Kingdom, NR1 3SR
- Norfolk & Norwich Hospital
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Nottingham, England, United Kingdom, NG5 1PB
- Nottingham City Hospital NHS Trust
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Oxford, England, United Kingdom, 0X3 7LJ
- Oxford Radcliffe Hospital
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Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden Hospital
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Westcliff-On-Sea, England, United Kingdom
- Southend General Hospital
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Scotland
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Edinburgh, Scotland, United Kingdom
- Royal Hospital for Sick Children
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Glasgow, Scotland, United Kingdom, G11 6NT
- Beatson Oncology Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven carcinoma of the breast with metastases No CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Sex: Female Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (no greater than 5 times ULN with liver metastases) Renal: Not specified Cardiovascular: Ejection fraction within normal range No history of cardiac disease including myocardial infarction, cardiac failure and angina Other: Not pregnant No prior or concurrent malignancy that is likely to interfere with protocol treatments or comparisons
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy other than adjuvant No prior high dose adjuvant chemotherapy requiring transplantation Cumulative dose of doxorubicin no greater than 300 mg/m2 permitted Cumulative dose of epirubicin no greater than 400 mg/m2 permitted At least 6 months since prior anthracyclines Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: James Carmichael, MD, PhD, Nottingham City Hospital
Publications and helpful links
General Publications
- Langley RE, Carmichael J, Jones AL, Cameron DA, Qian W, Uscinska B, Howell A, Parmar M. Phase III trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer: United Kingdom National Cancer Research Institute trial AB01. J Clin Oncol. 2005 Nov 20;23(33):8322-30. doi: 10.1200/JCO.2005.01.1817.
- Carmichael J: UKCCCR trial of epirubicin and cyclophosphamide (EC) vs. epirubicin and taxol (ET) in the first line treatment of women with metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-84, 2001.
- Carmichael J: UKCCCR trial of epirubucin and cyclophosphamide (EC) versus epirubicin and taxol (ET) in the first line treatment of women with metastatic breast cancer (MBC). [Abstract] Br J Cancer 85 (suppl 1): A-CT6, 2, 2001.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Paclitaxel
- Epirubicin
Other Study ID Numbers
- CDR0000065426
- MRC-UKCCCR-AB01
- EU-97002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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