NCT00431080

Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer

A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer

Detailed description

This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
DRUG	Paclitaxel	Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles
DRUG	Epirubicin	Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
DRUG	Cyclophosphamide	Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
DRUG	5-fluoruracil	5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
DRUG	Granulocyte-colony stimulating growth factor	rhG-CSF 5 μg/kg/d on days 3-10 after each cycle

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-02-05
• Last updated: 2008-01-21

Locations

10 sites across 1 country: Greece