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

NCT00847444 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3547

Last updated 2013-04-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Drug-based intervention

Randomization A AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicine 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22 AB: 6 cycles of Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² i.v. body surface area i.v. (DC), administered on day 1, repeated on day 22

BEHAVIORAL

Lifestyle-based Intervention

All Patients with a Body Mass Index (BMI) of 24 - 40 kg/m² at the time of enrollment will be subsequently randomized as follows: Second randomization B BA: Lifestyle intervention program to reduce body weight comprising individual weight loss, diet and physical activity goals in the framework of a 2-year standardized and structured telephone and mail-based intervention.

Sponsors & Collaborators

  • Philip Hepp

    lead OTHER

Principal Investigators

  • Wolfgang Janni, Prof. Dr. med. · Klinikum der Heinrich-Heine-Universität Düsseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-09-30
Completion
2016-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00847444 on ClinicalTrials.gov