| Erkrankung: | Brustkrebs (Mammakarzinom) |
| Status der Studie: | Studie rekrutiert |
| Studiendesign: | interventionell |
| Studienphase: | Phase II |
| Studienart: | Medikamentöse Therapie |
| Therapielinie: | Erstlinie |
| Haupteinschlusskritieren: | Metastatic breast cancer, which cannot be cured by surgery or radiotherapy. The primary tumor and/or biopsies must have be confirmed as cancer by histolopathology. · HER2 status (as investigated on all primary tumor tissue and/or biopsies from metastatic sites or loco regional recurrences) must be negative. HER2-negativity is defined as (i.e.: immunohistochemistry (IHC) score 0-1+ or 2+ and fluorescent in situ hybridization (FISH) negative or just FISH negative, whichever was performed) in all tissue samples · Evidence of CTCs. At least one CTC has been detected in 7.5 ml patient blood by means of the CellSearch® Circulating Tumor Cell Kit (Veridex LLC, Raritan, USA). · HER2 negativity of all detected CTCs. |
| Hauptausschlusskritieren: | 1. Treatment with other investigational agents of any type or anticancer therapy during the trial, within 2 weeks prior to the start of treatment. 2. Adverse events due to prior anticancer therapy which are > Grade 1 (NCI CTCAE) and therapeutically relevant at time of treatment start. 3. Known HIV infection. 4. Current active hepatitis B or C, cliniclally relevant known liver dysfunction, e.g. according to Child Pugh Classification class B and C, or biliary disease (with exception of patients with Gilbert‘s syndrome, asymptomatic gall-stones, liver metastases or stable chronic non-viral liver disease per investigator assessment). 5. Concurrent disease or condition that might interfere with adequate assessment or evaluation of study data, or any medical disorder that would make the patient‘s participation unreasonably hazardous. 6. Other malignant diseases within the last 3 years (apart from carcinoma in situ of the cervix or non-melanoma skin cancer) 7. Dementia, altered mental status, or any psychiatric or social condition which would prohibit the understanding or rendering of informed consent or which might interfere with the patient‘s adherence to the protocol. 8. Life expectancy < 3 months. 9. Male gender. |
| Prüfarzt: | Dr. med. Antje Lehnert |