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

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	Other	CRC-TU-NEAT EU-98041, NCT00003577

Objectives

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

Entry 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

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

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

Expected Enrollment

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

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

Earl HM, Hiller L, Dunn JA, et al.: NEAT: National Epirubicin Adjuvant Trial--toxicity, delivered dose intensity and quality of life. Br J Cancer 99 (8): 1226-31, 2008.[PUBMED Abstract]

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, et al.: Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer. N Engl J Med 355 (18): 1851-62, 2006.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Helena Earl, MBBS, PhD, FRCP, Protocol chair		Ph: 44-1223-336-800

Registry Information
Official Title		National Breast Cancer Study of Epirubicin + CMF v Classical CMF Adjuvant Therapy
Trial Start Date		1996-03-01
Registered in ClinicalTrials.gov		NCT00003577
Date Submitted to PDQ		1998-09-14
Information Last Verified		2001-02-07

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