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Combination Chemotherapy in Treating Women With Stage I Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00055679
First received: March 6, 2003
Last updated: June 17, 2013
Last verified: June 2013

March 6, 2003
June 17, 2013
August 2002
June 2012   (final data collection date for primary outcome measure)
Efficacy, in terms of 5-year survival [ Time Frame: 5 years from randomization ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00055679 on ClinicalTrials.gov Archive Site
  • Event free survival [ Time Frame: 5 years from randomization ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 5 years from randomization ] [ Designated as safety issue: Yes ]
  • Biological factors significant for prognosis and prediction of survival [ Time Frame: 5 years from randomization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy in Treating Women With Stage I Breast Cancer
Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

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.

OBJECTIVES:

  • 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: cyclophosphamide
  • Drug: epirubicin hydrochloride
  • Drug: fluorouracil
  • Active Comparator: 6 FEC
    6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
    Interventions:
    • Drug: cyclophosphamide
    • Drug: epirubicin hydrochloride
    • Drug: fluorouracil
  • Experimental: 4 FEC
    4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
    Interventions:
    • Drug: cyclophosphamide
    • Drug: epirubicin hydrochloride
    • Drug: fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1512
June 2013
June 2012   (final data collection date for primary outcome measure)

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

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

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

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00055679
PACS05 UC-0140-0106, FRE-FNCLCC-PACS-05/0106, EU-20239
Yes
UNICANCER
UNICANCER
Not Provided
Study Chair: Pierre Kerbrat, MD, PhD Centre Eugene Marquis
UNICANCER
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP