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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002953
Recruitment Status : Completed
First Posted : July 7, 2004
Last Update Posted : December 4, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: paclitaxel Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 704 participants
Primary Purpose: Treatment
Official Title: A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer
Study Start Date : December 1996
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002953

South Africa
Groote Schuur Hospital, Cape Town
Cape Town, South Africa, 7925
United Kingdom
University Birmingham
Birmingham, England, United Kingdom, B15 2TT
Bristol Royal Hospital for Sick Children
Bristol, England, United Kingdom, BS2 8BJ
Bristol Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
University Hospitals of Leicester
Leicester, England, United Kingdom, LE1 5WW
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, W1N 8AA
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, L63 4JY
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Norfolk & Norwich Hospital
Norwich, England, United Kingdom, NR1 3SR
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 7LJ
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
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, G11 6NT
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Medical Research Council
Study Chair: James Carmichael, MD, PhD Nottingham City Hospital

Publications of Results:
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. Identifier: NCT00002953     History of Changes
Other Study ID Numbers: CDR0000065426
First Posted: July 7, 2004    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2005

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors