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

Phase 3

Completed

• Conditions: Her2 Non-overexpressing; Primary Breast Cancer
• Interventions: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel

• Registration Number: NCT01049425
• Lead Sponsor: West German Study Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-05
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Primary Completion: 2017-03-01
• Study Completion: 2018-05-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3198

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epirubicin and Cyclophosphamid followed by Docetaxel	Epirubicin	4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
Epirubicin and Cyclophosphamid followed by Docetaxel	Docetaxel	4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
Combination of Docetaxel and Cyclophosphamid	Cyclophosphamide	intravenous infusion on day one every three weeks
Epirubicin and Cyclophosphamid followed by Docetaxel	Cyclophosphamide	4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
Combination of Docetaxel and Cyclophosphamid	Docetaxel	intravenous infusion on day one every three weeks

Primary Outcome Measures

Name	Time	Method
disease-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment	5 years

Trial Locations

Locations (1)

Bethesda Krankenhaus; 🇩🇪 Moenchengladbach, Germany