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Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: University Hospital Birmingham
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003577
  Purpose

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. It is not yet known whether combination chemotherapy plus epirubicin is more effective than combination chemotherapy alone for stage I or stage II breast cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and epirubicin in treating women with stage I or stage II breast cancer who have undergone surgery to remove the tumor.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: methotrexate
Procedure: adjuvant therapy
Procedure: radiation therapy
Phase III

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Cyclophosphamide    Methotrexate    Fluorouracil    Epirubicin hydrochloride    Epirubicin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   National Breast Cancer Study of Epirubicin + CMF v Classical CMF Adjuvant Therapy

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   2000
Study Start Date:   March 1996

Detailed Description:

OBJECTIVES:

  • Compare disease-free and overall survival of women with early stage breast cancer treated with adjuvant cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin.
  • Compare the quality of life in a subgroup of these patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy timing (concurrent versus sequential), nodal status (negative versus 1-3 versus at least 4), age (50 and under versus over 50), grade, and tumor size. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive oral cyclophosphamide on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses.
  • Arm II: Patients receive epirubicin IV on day 1 every 3 weeks for 4 courses followed by cyclophosphamide, methotrexate, and fluorouracil, as in arm I, for 4 courses.

Some patients may receive radiotherapy during or after chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed in a subset of patients (N=500) before chemotherapy starts, at 3 months of treatment, at the end of chemotherapy, and at 6, 12, and 18 months after treatment.

Patients are followed annually for 10 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 2,000 patients will be accrued for this study within 4 years.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histological confirmation of invasive, early stage breast cancer
  • Prior complete excision of tumor required (wide local excision or mastectomy)
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Pre-, peri-, or post-menopausal

Performance status:

  • Not specified

Hematopoietic:

  • Adequate bone marrow function

Hepatic:

  • Adequate hepatic function

Renal:

  • Adequate renal function

Other:

  • No prior cancer except for basal cell carcinoma or carcinoma in situ
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Concurrent hormone therapy allowed

Radiotherapy:

  • No prior radiotherapy
  • Concurrent radiotherapy allowed

Surgery:

  • See Disease Characteristics
  • No more than 6 weeks since prior surgery to the breast
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003577

Locations
United Kingdom, England
University of Cambridge    
      Cambridge, England, United Kingdom, CB2 2QQ

Sponsors and Collaborators
University Hospital Birmingham

Investigators
Study Chair:     Helena Earl, MBBS, PhD, FRCP     Cambridge University Hospitals NHS Foundation Trust    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications:
Earl H, Hiller L, Dunn JA, et al.: The National Epirubicin Adjuvant Trial (NEAT) and Scottish Cancer Trials Breast Group (SCTBG) br9601 randomized phase III adjuvant early breast cancer trials: the updated definitive joint analysis. [Abstract] J Clin Oncol 25 (Suppl 18): A-534, 11s, 2007.
Poole CJ, Earl HM, Hiller L, Dunn JA, Bathers S, Grieve RJ, Spooner DA, Agrawal RK, Fernando IN, Brunt AM, O'Reilly SM, Crawford SM, Rea DW, Simmonds P, Mansi JL, Stanley A, Harvey P, McAdam K, Foster L, Leonard RC, Twelves CJ; NEAT Investigators and the SCTBG. Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer. N Engl J Med. 2006 Nov 2;355(18):1851-62.
 
Poole CJ, Earl HM, Dunn JA, et al.: NEAT (National Epirubicin Adjuvant Trial) and SCTBG BR9601 (Scottish Cancer Trials Breast Group) phase III adjuvant breast trials show a significant relapse-free and overall survival advantage for sequential ECMF. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-13, 4, 2003.

Study ID Numbers:   CDR0000066644, CRC-TU-NEAT, EU-98041
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003577
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Folic Acid
Skin Diseases
Fluorouracil
Methotrexate
Breast Neoplasms
Cyclophosphamide
Epirubicin
Breast Diseases

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008




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