Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention Strategies
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
Wolfgang Janni, Prof. Dr. med.
Study Director
Klinikum der Heinrich-Heine-Universität Düsseldorf
Germany: Ethics Commission
SUCCESS-C Trial
NCT00847444
February 2009
September 2016
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