Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer
Tracking Information | |||||
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First Received Date ICMJE | November 16, 2005 | ||||
Last Updated Date | June 27, 2008 | ||||
Start Date ICMJE | September 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
To assess the feasibility of FEC and docetaxel based sequential regimens given in dose-dense fashion (FEC every 10-11 days and docetaxel every 14 days) with pegfilgrastim in patients with high-risk primary breast cancer. | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00256360 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
To assess the safety and tolerability of FEC and docetaxel regimens including (febrile) neutropenia | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer | ||||
Official Title ICMJE | A Randomized Phase II Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer | ||||
Brief Summary | The rationale of this randomized phase II study is to investigate the feasibility of sequenced densified FEC and docetaxel based regimens in patients with primary operable high-risk breast cancer. Several phase III and phase II clinical trials showed the benefits of dose-dense therapy (Q2W) over conventional treatment in breast cancer, lymphoma and SCLC. The aim of the study is also to demonstrate that further shortening of treatment interval from 14 days to 10-11 days in FEC regimen is feasible and will not compromise patient's safety. The results of this randomized phase II study should serve as a basis for follow-up randomized phase III trial comparing conventional versus densified sequential FEC and docetaxel based regimens. |
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Detailed Description | Arm A: The three cycles of conventional FEC followed by three cycles of docetaxel regimen will be given at the following doses: Fluorouracil 500 mg/m² by i.v. bolus or infusion, Epirubicin 100 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 500 mg/m² by i.v. bolus or infusion followed by docetaxel 100 mg/m2 i.v. infusion. All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors. Pegfilgrastim is only allowed in secondary prophylaxis: febrile neutropenia or prolonged grade IV neutropenia. In the event of febrile neutropenia or prolonged grade IV neutropenia, pegfilgrastim or filgrastim is given for treatment, and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy. The total duration of treatment is 18 weeks. Arm B: The three cycles of conventional docetaxel followed by three cycles of FEC regimen will be given at the following doses: Docetaxel 100 mg/m2 i.v. infusion followed by Fluorouracil 500 mg/m² by i.v. bolus or infusion, Epirubicin 100 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 500 mg/m² by i.v. bolus or infusion. All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors. Pegfilgrastim is only allowed in secondary prophylaxis: febrile neutropenia or prolonged grade IV neutropenia. In the event of febrile neutropenia or prolonged grade IV neutropenia, pegfilgrastim or filgrastim is given for treatment, and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy. The total duration of treatment is 18 weeks. Arm C: The four cycles of dose-dense FEC followed by four cycles dose-dense docetaxel regimen will be given at the following doses: Fluorouracil 375 mg/m² by i.v. bolus or infusion, Epirubicin 75 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 375 mg/m² by i.v. bolus or infusion followed by docetaxel 75 mg/m2. FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle and docetaxel will be given on Day 1 of each 14-day cycle. Pegfilgrastim (Neulasta) fixed dose of 6 mg (0.6 mL of a 10 mg/mL solution) as a single subcutaneous injection will be given in on Day 2 of each study cycle. The total duration of treatment is 14 weeks. Arm D: The four cycles of dose-dense docetaxel followed by four cycles dose-dense FEC regimen will be given at the following doses: Docetaxel 75 mg/m² followed Fluorouracil 375 mg/m² by i.v. bolus or infusion, Epirubicin 75 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 375 mg/m² by i.v. bolus or infusion. Docetaxel will be given on Day 1 of each 14-day cycle and FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle. Pegfilgrastim (Neulasta) fixed dose of 6 mg (0.6 mL of a 10 mg/mL solution) as a single subcutaneous injection will be given on Day 2 of each study cycle. The total duration of treatment is 14 weeks. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Drug: dose dense with neulasta | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 117 | ||||
Completion Date | May 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Gender | Female | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Belgium | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256360 | ||||
Other Study ID Numbers ICMJE | 2005-001876-11 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | University Hospital, Gasthuisberg | ||||
Collaborators ICMJE | St-Augustinus Wilrijk | ||||
Investigators ICMJE |
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Information Provided By | University Hospital, Gasthuisberg | ||||
Verification Date | June 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |