patients with HER2 negative metastatic breast cancer
Conditions
Interventions
Sponsors
GBG Forschungs GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. 2. Histologically confirmed carcinoma of the breast. 3. Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH. 4. Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone. 5. The following previous systemic treatment are eligible: adjuvant chemotherapy (except if capecitabine was included) adjuvant endocrine therapy palliative endocrine treatments treatment with bisphosphonates (adjuvant and/or palliative) treatment with immunotherapies (adjuvant and/or palliative) 6. Patients must have either measurable or nonmeasurable target lesions according to the WHO criteria (see Appendix 6 ). 7. At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease. 8. Complete radiology and tumor measurement work up within 4 weeks prior to registration. 9. Karnofsky performance status evaluation ? 60% 10. Age >18 years. 11. Absolute neutrophil count ?1,500 cells/?l, platelet count ?100,000 cells/?l. 12. Bilirubin ? 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase 50 ml/min (according to Cockroft Gault). 14. If of childbearing potential, negative pregnancy test. In addition the patient has to agree to use an effective method to avoid pregnancy for the duration of the study. 15. female and male patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency. 2. Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued. 3. Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and of all steroids. 4. Life expectancy of less than 3 months. 5. Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection). 6. History of other malignancy within the last 5 years which could affect the diagnosis or assessment of metastatic breast cancer. 7. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. 8. Treatment with sorivudine or derivates e.g. brivudin. 9. Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the time to disease progression in patients with HER2 negative metastatic breast cancer after 1st line monochemotherapy with capecitabine;Secondary Objective: To determine the objective response rate To determine the duration of response To determine the clinical benefit defined as CR, PR, or stable disease > 24 weeks To evaluate the safety and toxicity of capecitabine To assess quality of life within 1 year after start of capecitabine treatment To determine overall survival To determine the objective response rate in male patients To evaluate QoL the modified Brunner Score ;Primary end point(s): Any progression of disease or disease related death of a patient | — |
Countries
Germany
Outcome results
None listed