Table 3 Inclusion criteria of the SUCCESS studies
SUCCESS A | SUCCESS B | SUCCESS C |
|---|---|---|
Primary epithelial invasive breast carcinoma pT1-4, pM0 | Primary epithelial invasive breast carcinoma pT1-4, M0 | Primary epithelial invasive breast carcinoma pT1-4, pN0-3, pM0 |
HER2neu positive tumor (IHC+++ or FISH+) | HER2neu-negative tumor (IHC neg. or 1+ or FISH neg) | |
Histological evidence of axillary lymph node metastases pN1-3 or nodal negative high-risk patients N0/X, defined as pT > 2 or histopathological grading 3 or age ≤ 35 or negative hormone receptor status | Histological evidence of axillary lymph node metastases pN1-3 or nodal negative high-risk patients N0/X, defined as pT > 2 or histopathological grading 3 or age ≤ 35 or negative hormone receptor status | Histological evidence of axillary lymph node metastases pN1-3 or nodal negative high-risk patients N0/X, defined as pT > 2 or histopathological grading 3 or age ≤ 35 or negative hormone receptor status |
R0 resection of the primary tumor (resection margins free of invasive carcinoma tissue), maximum 6 weeks ago | R0 resection of the primary tumor (resection margins free of invasive carcinoma tissue), maximum 6 weeks ago | R0 resection of the primary tumor (resection margins free of invasive carcinoma tissue), no more than 6 weeks ago |
Women older than 18 years | Women older than 18 years | Women older than 18 years |
General condition ≤ 2 on the ECOG scale | General condition ≤ 2 on the ECOG scale | General condition ≤ 2 on the ECOG scale |
Adequate bone marrow reserve: leukocytes ≥ 3.0 × 109/l and platelets ≥ 100 × 109/l | Adequate bone marrow reserve: leukocytes ≥ 3.0 × 109/l and platelets ≥ 100 × 109/l | Adequate bone marrow reserve: leukocytes ≥ 3.0 × 109/l and platelets ≥ 100 × 109/l |
Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase within 1.5 times the normal value of the respective reference laboratory | Alanine aminotransferase, aspartate aminotransferase, bilirubin, and alkaline phosphatase within 1.5 times the normal value of the respective reference laboratory | Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase within 1.5 times the normal value of the respective reference laboratory |
Ensure regular follow-up during the study period | Ensure regular follow-up during the study period | Ensure regular follow-up during the study period |
Understanding of the study concept and written informed consent | Understanding of the study concept and written informed consent | Understanding of the study concept and written informed consent |
R0 resection of the primary tumor (resection margins free of invasive carcinoma tissue), maximum 6 weeks ago | Use of an effective contraceptive method (Pearl index < 1) in women of childbearing age during therapy and for at least 6 months afterward. Intrauterine pessaries (copper IUD) or surgical tubal ligation are considered safe methods of contraception | Patient is willing to participate in telephone-based lifestyle intervention |