metastatic HER2-negative breast cancer
Conditions
Interventions
Trade Name: Nexavar
Product Code: L01XE05
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed stage IV adenocarcinoma of the breast or inoperable local relapse 2. Female patients with HER2 negative breast cancer (latest assessment) 3. Patients requiring first line mono-chemotherapy with taxanes 4. Age > 18 years. 5. ECOG Performance Status of = 2 6. Life expectancy of at least 12 weeks. 7. Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT-scan or MRI 8. No prior chemotherapy for locally recurrent or metastatic disease 9. At least 12 months since prior adjuvant or neoadjuvant taxane therapy; endocrine treatment for early breast cancer is allowed and patients may have failed hormonal therapy in the metastatic stage, if they are ER/PgR-positive. 10. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: 11. Hemoglobin > 9.0 g/dl 12. Absolute neutrophil count (ANC) >1.500/mm3 13. Platelet count ? 100.000/µl 14. Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. 2. History of HIV infection or chronic hepatitis B or C 3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0) 4. Prior radiological or clinical evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI 5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) 6. History of organ allograft 7. Patients with evidence or history of bleeding diathesis 8. Patients undergoing renal dialysis 9. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry. Excluded therapies and medications, previous and concomitant: 10. Anticancer chemotherapy or immunotherapy (including mistletoe) during the study or within 3 weeks of study entry. Hormone therapy parallel to study treatment is not allowed, but no wash-out period is necessary. 11. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy of non-target lesions will be allowed). 12. Major surgery within 4 weeks of start of study 13. Autologous bone marrow transplant or stem cell rescue within 4 months of study 14. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study] 15. Investigational drug therapy outside of this trial during or within 4 weeks of study entry 16. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial. 17. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results 18. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study 19. Patients unable to swallow oral medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate progression-free survival (PFS) of a combination treatment with docetaxel 75 mg/m2 and sorafenib 400 mg bid every 3 weeks in subjects with MBC as per RECIST tumor response criteria.; Secondary Objective: - To analyze the duration of response, time to disease progression and overall survival time. - To evaluate patient reported outcome / Quality of life (FACT B) - Safety and tolerability - Correlate baseline and change in tumor and serum genetic and proteomic patterns with clinical response (optional protocol supplement) ;Primary end point(s): Progression Free Survival | — |
Countries
Germany
Outcome results
None listed