Effect of SBG in Patients With Breast Cancer

Inclusion criteria

• Women with histologically/cytologically confirmed locally advanced or metastatic breast cancer
• Primary tumor or metastases are HER2-ICH3+ or FISH+
• Measurable or non-measurable disease
• The patients must not have received treatment with the combination trastuzumab and vinorelbine previously
• Expected lifetime of more than 12 weeks
• Age ≥ 18 years
• Performance status ≤ 2 according to World Health Organization (WHO) scale
• The patient must be able to comply with the protocol
• Verbal and written informed consent

Exclusion criteria

• Women who are pregnant or breast-feeding. A negative pregnancy test must be provided during the screening period for fertile women. Fertile women must use effective contraceptive methods
• Clinical symptoms indicating central nervous system involvement
• Other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas
• Left ventricular ejection fraction (LVEF) < 50% of normal range
• Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l and neutrophil counts < 1.5 x 109/l, or thrombocyte counts ≤ 100 x 109/l
• Reduced liver function defined by bilirubin > 3 x upper normal limit and/or ASAT/ALAT > 3 x upper normal limit and/or alkaline phosphatase > 3 x upper normal limit.
• Reduced renal function defined by serum creatinine > 2 x upper normal limit