Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||December 3, 2013|
|Start Date ICMJE||December 1996|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00002953 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer|
|Official Title ICMJE||A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic 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.
PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.
OBJECTIVES: I. Compare the activity and toxicity of epirubicin and cyclophosphamide with that of epirubicin and paclitaxel in patients with metastatic breast cancer.
OUTLINE: Patients are randomized to receive either epirubicin and cyclophosphamide or epirubicin and paclitaxel. Each drug combination is given every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Breast Cancer|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||704|
|Completion Date||November 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically proven carcinoma of the breast with metastases No CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Sex: Female Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (no greater than 5 times ULN with liver metastases) Renal: Not specified Cardiovascular: Ejection fraction within normal range No history of cardiac disease including myocardial infarction, cardiac failure and angina Other: Not pregnant No prior or concurrent malignancy that is likely to interfere with protocol treatments or comparisons
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy other than adjuvant No prior high dose adjuvant chemotherapy requiring transplantation Cumulative dose of doxorubicin no greater than 300 mg/m2 permitted Cumulative dose of epirubicin no greater than 400 mg/m2 permitted At least 6 months since prior anthracyclines Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||South Africa, United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00002953|
|Other Study ID Numbers ICMJE||CDR0000065426
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Medical Research Council|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||December 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP