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

December 3, 2013 updated by: Medical Research Council

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

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

704

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Investigators

Study Chair: James Carmichael, MD, PhD, Nottingham City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 6, 2004

First Posted (Estimate)

July 7, 2004

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

stage IV breast cancer

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000065426
MRC-UKCCCR-AB01
EU-97002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.