Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention
Status:
Unknown status
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
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.