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

Breast Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00256360
• Study type: Interventional
• Source: Universitaire Ziekenhuizen Leuven
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Completion date: May 2006