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

Alternate Title

Combination Chemotherapy in Treating Women With Stage I Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 65	Other	FRE-FNCLCC-PACS-05/0106 EU-20239, NCT00055679

Objectives

1. Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil, epirubicin, and cyclophosphamide, in terms of 5-year survival, in women with stage I breast cancer.
2. Compare the toxicity of these regimens in these patients.
3. Determine the correlation of length of survival with biological factors in patients treated with these regimens.
4. Determine biological factors significant for prognosis and prediction of survival of patients treated with these regimens.
5. Determine the overall survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
  • Stage I
  • No clinically or radiologically suspicious metastases
  • No positive sentinel lymph nodes by immunohistochemistry for tumors less than 2 cm
  • No clinically proven positive axillary lymph nodes
    • Tumor cells found on immunohistochemistry only allowed
  • No clinically or radiologically contralateral suspicious lesions



• No deeply adherent disease



• No cutaneous invasion



• No inflammatory disease



• Complete surgical resection within the past 42 days
  • At least 8 lymph nodes removed



• Tumor at least 1 cm with no residual disease



• Presenting with at least 1 of the following factors of a poor prognosis:
  • Tumor greater than 2 cm
  • Hormone receptor negative tumor
  • Grade II or III
  • 35 years old or under



• Hormone receptor status:
  • Positive or negative

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No prior anticancer hormone therapy

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 to 65

Sex

• Female

Menopausal status

• Not specified

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• AST and ALT no greater than 1.25 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• No chronic hepatitis B
• No active hepatitis C

Renal

• Creatinine no greater than 1.25 times ULN

Pulmonary

• FEV normal

Other

• Not pregnant or nursing
• HIV negative
• No prior breast cancer or other malignancy
• No familial, social, or geographical reason that would preclude study participation

Expected Enrollment

A total of 1,512 patients (756 per treatment arm) will be accrued for this study within 3 years.

Outcomes

Efficacy, in terms of 5-year survival
Toxicity
Length of survival with biological factors
Biological factors significant for prognosis and prediction of survival
Overall survival

Outline

This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive the same regimen as in arm I for up to 4 courses.

After completion of chemotherapy, patients undergo radiotherapy 5 days a week for 6 weeks. Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen daily for 5 years, beginning after completion of chemotherapy.

Patients are followed every 6 months for 5 years.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Pierre Kerbrat, MD, PhD, Protocol chair		Ph: 33-299-253-280 Email: kerbrat@rennes.fnclcc.fr

Registry Information
Official Title		Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer
Trial Start Date		2002-08-20
Registered in ClinicalTrials.gov		NCT00055679
Date Submitted to PDQ		2003-01-08
Information Last Verified		2006-12-03

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