Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biotec Pharmacon ASA
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Women with histologically/cytologically confirmed locally advanced or metastatic breast cancer
2. Primary tumor or metastases are HER2-ICH3+ or FISH+
3. Measurable or non-measurable disease
4. The patients must not have received treatment with the combination trastuzumab and vinorelbine previously
5. Expected lifetime of more than 12 weeks
6. Age ≥ 18 years
7. Performance status ≤ 2 according to World Health Organization (WHO) scale
8. The patient must be able to comply with the protocol
9. Verbal and written informed consent
You may not be if
1. 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
2. Clinical symptoms indicating central nervous system involvement
3. Other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas
4. Left ventricular ejection fraction (LVEF) \< 50% of normal range
5. 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
6. 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.
7. Reduced renal function defined by serum creatinine \> 2 x upper normal limit
