NCT01049425

Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,198 (actual)
• Sponsor: West German Study Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy. Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.

Conditions

• Primary Breast Cancer
• Her2 Non-overexpressing

Interventions

Type	Name	Description
DRUG	Epirubicin	4 cycles, intravenous use, day 1 every three weeks
DRUG	Cyclophosphamide	4 cycles, intravenous infusion, day 1 every three weeks
DRUG	Docetaxel	4 cycles, intravenous infusion, day 1 every three weeks after completion of EC-chemotherapy
DRUG	Cyclophosphamide	6 cycles, intravenous infusion, day 1 every 3 weeks
DRUG	Docetaxel	6 cycles, intravenous infusion, day one every three weeks

Timeline

• Start date: 2009-02-05
• Primary completion: 2017-03-01
• Completion: 2018-05-15
• First posted: 2010-01-14
• Last updated: 2019-08-14

Locations

1 site across 1 country: Germany