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Abstract
Objective There is growing evidence from observational studies that lifestyle factors such as obesity, an unhealthy diet and lack of physical activity are associated with poor long-term outcome in women with breast cancer. The primary objective of the lifestyle modification part of the Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as well as Life Style Intervention Strategies (SUCCESS C) Trial is to investigate the effect of an individualised lifestyle intervention programme aiming at moderate weight loss on disease-free survival in women with HER2/neu-negative breast cancer. Secondary objectives include the effect of the intervention on body weight, cardiovascular risk and quality of life.
Methods The SUCCESS C Trial is an open-label, multicentre, randomised controlled phase III study using a 2×2 factorial design in women with newly diagnosed HER2/neu-negative intermediate-risk to high-risk breast cancer. The first randomisation served to compare disease-free survival in patients treated with two different chemotherapy regimens (3642 participants). The second randomisation served to compare disease-free survival in patients with a body mass index of 24–40 kg/m² (2292 participants) receiving either a telephone-based individualised lifestyle intervention programme for moderate weight loss or general recommendations for a healthy lifestyle for 2 years. Outcome analyses will be conducted after 5 years of follow-up.
Perspective This study will provide information on the efficacy and safety of a comprehensive lifestyle intervention programme on disease-free survival in a large cohort of women with breast cancer. EU Clinical Trials Identifier: 2008-005453-38.
- weight management
- dietary patterns
- mental health
- nutrition assessment
- preventive counselling
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Footnotes
Contributors WJ designed the SUCCESS C Trial. DH, BR and HH developed the lifestyle part of the SUCCESS C Trial. DH supervised the lifestyle coaching. TF is responsible for statistics. BR and PH were responsible for supervision and support of the study centers. DH and HH were mainly responsible for the preparation of the manuscript. BR, TF, PH and WJ reviewed and commented on the manuscript.
Funding This study was supported by unrestricted grants from Pfizer, Sanofi-Aventis, Chugai and Veridex. Additional funding was received from the Bavarian Ministry of Health (Project No. 89397) as well as by the Else Kroener-Fresenius Foundation, Bad Homburg (Grant No. 2016_A31). Preparation of the manuscript was independent from funders.
Competing interests BR reports grants from Sanofi Aventis, grants from Chugai, grants from Pfizer, grants from GSK, grants from Janssen Diagnostics, during the conduct of the study. WJ reports grants from Sanofi Aventis, grants and personal fees from Chugai, grants and personal fees from Pfizer, grants and personal fees from GSK, grants from Janssen Diagnostics, during the conduct of the study. HH reports personal fees from Novo Nordisk, advisory board, personal fees from Danone Germany, advisory board, outside the submitted work.
Patient consent for publication Not required.
Ethics approval The study protocol was approved by the ethics committee of the Heinrich-Heine-University Düsseldorf.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. All data relevant to the study are included in the article or uploaded as supplementary information. No data on study results available yet.