Her-2 negative metastatic or locally advanced inoperable breast cancer MedDRA version: 17.0 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Nexavar
Product Name: Sorafenib
Product Code: Not Applicable
Pharmaceutical Form: Coated tablet
INN or Proposed INN: SORAFENIB
CAS Number: 284461-73-0
Current Sponsor code: BAY 43-9006
Con
Sponsors
GMIHO mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the breast 2. HER-2/neu negative (primary tumour site HER-2/neu negative by ICH/FISH test) 3. Second till third-line of cytostatics based chemotherapy 4. Female, age = 18 years. 5. ECOG Performance Status of 0 or 1 (Karnofsky-Index = 70%) 6. Life expectancy of at least 12 weeks. 7. Subjects with at least one uni-dimensional (for RECIST 1.1) measurable lesion. Lesions must be measured by Xray (pulmonary lesions only) or CT-scan or MRI (Patients with only measurable bone lesions can be also included, as long they meet the criteria for RECIST 1.1. Means, lytic bone lesions or mixed lytic-blastic bone lesions with identifiable soft tissue components.) 8. No prior therapy for locally recurrent or metastatic disease with TKI’s (RAS/Raf, MEK, AKT), mTOR inhibitors and angiogenesis inhibitors (VEGV/VEGFR, PDGF/PDGFR) but bevacizumab will be allowed. 9. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: Hemoglobin = 9.0 g/dl Absolute neutrophil count (ANC) = 1,500/mm3 Platelet count = 100,000/µl Total bilirubin = 1.5 x upper limit of normal ALT and AST = 2.5 x upper limit of normal (=65 years) yes F.1.3.1 Number of subjects for this age range 148
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. Known history of HIV infection or chronic hepatitis B or C 3. Active clinically serious infections (> grade 2 NCI-CTC version 4.0) 4. Prior clinical or radiological evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by contrast enhanced 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 tumours [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry. 10. 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. 11. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results 12. Any condition that is unstable or could jeopardise the safety of the patient and their compliance in the study 13. Patients unable to swallow oral medications. 14. Patients with intolerance to Paclitaxel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This Study will assess the potential prolongation in progression free survival in patients with metastatic breast cancer in combination with standard chemotherapy paclitaxel compared with the paclitaxel monotherapy.;Secondary Objective: - Clinical benefit (CR+PR+SD) - ORR (CR+PR) - Time to progression - Time to next Treatment (TTT) - Overall survival - Safety profile ;Primary end point(s): The primary study objective is the proof of efficacy, measured by progression free survival (PFS) in the treatment of metastatic or locally inoperable recurrent breast cancer. Progression-free survival (PFS) is defined as the time from randomisation to disease progression or death or start of a different antineoplastic therapy (without disease progression). ;Timepoint(s) of evaluation of this end point: 12/2014 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical benefit (CR+PR+SD) - ORR (CR+PR) - Time to progression - time to netx treatment (TTT) - overall survival - safety profile;Timepoint(s) of evaluation of this end point: 12/2014 | — |
Countries
Germany
Contacts
Public ContactCRO
iOMEDICO AG
Outcome results
None listed