Combination Chemotherapy in Treating Women With Stage I Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00055679|
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : June 18, 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 or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1512 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2013|
Active Comparator: 6 FEC
6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
Drug: epirubicin hydrochloride
Experimental: 4 FEC
4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
Drug: epirubicin hydrochloride
- Efficacy, in terms of 5-year survival [ Time Frame: 5 years from randomization ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055679
|Study Chair:||Pierre Kerbrat, MD, PhD||Centre Eugene Marquis|