Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention

Phase 3

• Conditions: Breast Cancer
• Interventions: Behavioral: Lifestyle-based Intervention; Drug: Drug-based intervention

• Registration Number: NCT00847444
• Lead Sponsor: Philip Hepp

Brief Summary

This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy, versus 6 cycles of Docetaxel- Cyclophosphamide (DC)-chemotherapy, and to compare the disease free survival in patients with BMI of 24 - 40 kg/m² after randomisation with versus without the lifestyle intervention. Patients will be required to have histopathological proof of a HER2/neu negative tumor and: axillary lymph node metastases (pN1-3) or high risk node negative, defined as: 'pT ≥2 or histopathological grade 3, or age ≤35 or negative hormone receptor status, but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study.

Detailed Description

Rationale:

* Taxane based chemotherapy will be established as treatment standard in the adjuvant setting of early breast cancer

* 3xFEC100, followed by 3xDoc100 has been established as standard treatment option for node-positive breast cancer

* Anthracycline based regimens do not seem to be superior in Her2/neu-negative patients (Gennari et al., Slamon et al.)

* Dietary intervention can improve outcome in patients with early breast cancer (WINS, Chlebowski et al.)

Primary Endpoints:

* The first primary objective of this study is to compare disease free survival after randomisation in patients treated with a combination of 5-FU/Epirubicine/Cyclophosphamide followed by Docetaxel vs. Docetaxel/Cyclophosphamide

* The second primary objective of this study is to compare disease free survival after randomisation in patients with vs. without lifestyle intervention

Design:

Prospectively randomized open label Phase III study with 2x2 factorial design

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Primary Completion: 2011-09
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-19
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3547

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BA	Lifestyle-based Intervention	Lifestyle intervention
AA	Drug-based intervention	Drug intervention

Primary Outcome Measures

Name	Time	Method
The first primary objective of this study is to compare disease free survival after randomisation in patients treated with a combination of 5-FU/Epirubicine/Cyclophosphamide followed by Docetaxel vs. Docetaxel/Cyclophosphamide	60 months

Secondary Outcome Measures

Name	Time	Method
The second primary objective of this study is to compare disease free survival after randomisation in patients with vs. without lifestyle intervention	60 months

Trial Locations

Locations (1)

Frauenklinik der Heinrich Heine Universität; 🇩🇪 Düsseldorf, Germany