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Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

Phase 3
18 Years
65 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer


- 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.

- Compare the toxicity of these regimens in these patients.

- Determine the correlation of length of survival with biological factors in patients
treated with these regimens.

- Determine biological factors significant for prognosis and prediction of survival of
patients treated with these regimens.

- Determine the overall survival of patients treated with these regimens.

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.

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

Inclusion Criteria


- 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

- 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



- 18 to 65


- Female

Menopausal status

- Not specified

Performance status

- WHO 0-1

Life expectancy

- Not specified


- WBC at least 2,000/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine no greater than 1.25 times ULN


- FEV normal


- Not pregnant or nursing

- HIV negative

- No prior breast cancer or other malignancy

- No familial, social, or geographical reason that would preclude study participation


Biologic therapy

- Not specified


- No prior chemotherapy

Endocrine therapy

- No prior anticancer hormone therapy


- No prior radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy, in terms of 5-year survival

Outcome Time Frame:

5 years from randomization

Safety Issue:


Principal Investigator

Pierre Kerbrat, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Eugene Marquis


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

PACS05 UC-0140-0106



Start Date:

August 2002

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • Breast Neoplasms