NCT00424606

Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients

A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 658 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles
DRUG	Epirubicin	Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles
DRUG	Epirubicin	Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
DRUG	Docetaxel	Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles

Timeline

• Start date: 2001-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2007-01-19
• Last updated: 2015-05-20

Locations

12 sites across 1 country: Greece