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Phase III Study of Epirubicin and Cyclophosphamide Versus Epirubicin and Paclitaxel in Women With Metastatic Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Closed Not specified MRC-UKCCCR-AB01
EU-97002, NCT00002953

Objectives

I.  Compare the activity and toxicity of epirubicin and cyclophosphamide with 
that of epirubicin and paclitaxel in patients with metastatic breast cancer.

Entry Criteria

Disease Characteristics:


Histologically proven carcinoma of the breast with metastases

No CNS metastases

Hormone receptor status:
 Not specified

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

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

Expected Enrollment

704

A total of 704 patients will be accrued for this study.

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.

Published Results

Langley RE, Carmichael J, Jones AL, et al.: 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 23 (33): 8322-30, 2005.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

James Carmichael, MD, PhD, Protocol chair(Contact information may not be current)
Ph: 44-115-969-1169

Registry Information

Official Title		A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women with Metastatic Breast Cancer

Trial Start Date		1996-12-01

Registered in ClinicalTrials.gov		NCT00002953

Date Submitted to PDQ		1996-12-01

Information Last Verified		2005-12-02

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.