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Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Registration Number
NCT00002953
Lead Sponsor
Medical Research Council
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
704
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (19)

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

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Groote Schuur Hospital, Cape Town
🇿🇦Cape Town, South Africa
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