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Combination Chemotherapy in Treating Women With Stage I Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
UNICANCER Identifier:
First received: March 6, 2003
Last updated: June 17, 2013
Last verified: June 2013

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 which combination chemotherapy regimen is more effective in treating early breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.

Condition Intervention Phase
Breast Cancer Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

Resource links provided by NLM:

Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Efficacy, in terms of 5-year survival [ Time Frame: 5 years from randomization ]

Secondary Outcome Measures:
  • Event free survival [ Time Frame: 5 years from randomization ]
  • Toxicity [ Time Frame: 5 years from randomization ]
  • Biological factors significant for prognosis and prediction of survival [ Time Frame: 5 years from randomization ]

Enrollment: 1512
Study Start Date: August 2002
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 6 FEC
Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil
Experimental: 4 FEC
Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00055679

  Show 72 Study Locations
Sponsors and Collaborators
Study Chair: Pierre Kerbrat, MD, PhD Centre Eugene Marquis
  More Information

Responsible Party: UNICANCER Identifier: NCT00055679     History of Changes
Other Study ID Numbers: PACS05 UC-0140-0106
Study First Received: March 6, 2003
Last Updated: June 17, 2013

Keywords provided by UNICANCER:
stage I breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017