Table 4 Exclusion criteria of the SUCCESS studies
SUCCESS A | SUCCESS B | SUCCESS C |
|---|---|---|
Inflammatory breast carcinoma | Inflammatory breast carcinoma | Inflammatory breast carcinoma |
Prior or concurrent therapy with other cytotoxic or antineoplastic drugs that were not included within the study protocol | Prior or concurrent therapy with other cytotoxic or antineoplastic drugs that were not included within the study protocol | Prior or concurrent therapy with other cytotoxic or antineoplastic drugs that were not included within the study protocol |
Secondary carcinoma (other than in situ carcinoma of the uterine cervix or adequately treated basal cell carcinoma) | Secondary carcinoma (other than in situ carcinoma of the uterine cervix or adequately treated basal cell carcinoma) | Secondary carcinoma (other than in situ carcinoma of the uterine cervix or adequately treated basal cell carcinoma) |
Manifest cardiac impairment (cardiomyopathy with reduced ventricular function (NYHA > II), arrhythmias requiring therapy affecting LVEF, recent myocardial infarction or angina pectoris within the last 6 months, hypertension not controlled by medication) | Manifest cardiac impairment (cardiomyopathy with reduced ventricular function (NYHA > II), arrhythmias requiring therapy affecting LVEF, recent myocardial infarction or angina pectoris within the last 6 months, hypertension not controlled by medication) | Manifest cardiac impairment (cardiomyopathy with reduced ventricular function (NYHA > II), arrhythmias requiring therapy affecting LVEF, recent myocardial infarction or angina pectoris within the last 6 months, hypertension not controlled by medication) |
Any known hypersensitivity to docetaxel, epirubicin, cyclophosphamide, fluorouracil, gemcitabine, or any other study drug | Any known hypersensitivity to docetaxel, epirubicin, cyclophosphamide, fluorouracil, gemcitabine, or other study drugs. The contraindications, warnings, or precautions listed in the product information of the approved preparations must be observed | Any known hypersensitivity to docetaxel, epirubicin, cyclophosphamide, or any other study drug |
Use of any study drug within the last 3 weeks prior to study inclusion | Use of any study drug within the last 3 weeks prior to study inclusion | Use of any study drug within the last 3 weeks prior to study inclusion |
Previous treatment with bisphosphonates within the last 6 months | Patients who are pregnant or breastfeeding (contraception must be ensured in premenopausal women): Intrauterine devices, surgical sterilization or, only in hormone receptor negative breast cancer patients, oral, subcutaneous, or transvaginal non-estrogen containing contraceptives) | Patients who are pregnant or breastfeeding (safe contraception must be ensured for premenopausal women: IUD or sterilization) |
Patients who are pregnant or breastfeeding (contraception must be ensured in premenopausal women): Intrauterine devices, surgical sterilization or, in hormone receptor negative breast cancer patients only, oral, subcutaneous, or transvaginal non-estrogen containing contraceptives) | Poorly controlled, uncontrolled or unstable diabetes mellitus | Diabetes mellitus type 1 or insulin-dependent diabetes mellitus type 2 |
Impaired renal function demonstrated by calculated creatinine clearance of ≤ 30 ml/min, calculated according to the Cockcroft-Gault formula | Significant disorders of absorption or digestive capacity that prohibit the use of the study diet | |
Existing dental complaints, mandibular, and dental inflammation or acute or pre-existing necrosis of the jaws. Exposed bones in the oral cavity, or of slow-healing wounds after dental treatment | Self-reported inability to walk one kilometer at any speed | |
Recent (6 weeks) or planned dental or jaw surgery (extractions, implants) | Cardiovascular, respiratory, or musculoskeletal disease or joint problems that prevent moderate physical activity. This does not include moderate arthritis | |
Psychiatric disorders that make participation in the intervention impossible | ||
Patients who do not have sufficient command of the German language to understand the nature of the study or the intervention measures included |