Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00002953
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
704 participants
INTERVENTIONAL
1996-12-31
2005-11-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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cyclophosphamide
epirubicin hydrochloride
paclitaxel
Eligibility Criteria
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Inclusion Criteria
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
FEMALE
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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James Carmichael, MD, PhD
Role: STUDY_CHAIR
Nottingham City Hospital
Locations
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Groote Schuur Hospital, Cape Town
Cape Town, , South Africa
University Birmingham
Birmingham, England, United Kingdom
Bristol Royal Hospital for Sick Children
Bristol, England, United Kingdom
Bristol Oncology Centre
Bristol, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Cookridge Hospital
Leeds, England, United Kingdom
University Hospitals of Leicester
Leicester, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk & Norwich Hospital
Norwich, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Southend General Hospital
Westcliff-on-Sea, England, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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References
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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.
Other Identifiers
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MRC-UKCCCR-AB01
Identifier Type: -
Identifier Source: secondary_id
EU-97002
Identifier Type: -
Identifier Source: secondary_id
CDR0000065426
Identifier Type: -
Identifier Source: org_study_id