Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: cyclophosphamide (Drug); epirubicin hydrochloride (Drug); paclitaxel (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Medical Research Council Official(s) and/or principal investigator(s):
James Carmichael, MD, PhD, Study Chair, Affiliation: Nottingham City Hospital NHS Trust
Summary
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.
Clinical Details
Official title: A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer
Study design: 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Groote Schuur Hospital, Cape Town, Cape Town 7925, South Africa
Royal Preston Hospital, Preston PR2 9HT, United Kingdom
Bristol Oncology Centre, Bristol, England BS2 8ED, United Kingdom
Bristol Royal Hospital for Sick Children, Bristol, England BS2 8BJ, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England L63 4JY, United Kingdom
Cookridge Hospital, Leeds, England LS16 6QB, United Kingdom
Derbyshire Royal Infirmary, Derby, England DE1 2QY, United Kingdom
Middlesex Hospital- Meyerstein Institute, London, England W1N 8AA, United Kingdom
Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom
Newcastle General Hospital, Newcastle Upon Tyne, England NE4 6BE, United Kingdom
Norfolk & Norwich Hospital, Norwich, England NR1 3SR, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom
Oxford Radcliffe Hospital, Oxford, England 0X3 7LJ, United Kingdom
Royal Marsden Hospital, Sutton, England SM2 5PT, United Kingdom
Southend General Hospital, Westcliff-On-Sea, England, United Kingdom
University Birmingham, Birmingham, England B15 2TT, United Kingdom
University Hospitals of Leicester, Leicester, England LE1 5WW, United Kingdom
Beatson Oncology Centre, Glasgow, Scotland G11 6NT, United Kingdom
Royal Hospital for Sick Children, Edinburgh, Scotland, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1996
Last updated: May 23, 2008
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