None listed
Conditions
Interventions
APPROXIMATELY 519 SUBJECTS WILL BE RANDOMIZED IN A 1:1 RATIO TO RECEIVE EITHER SORAFENIB IN COMBINATION WITH CAPECITABINE, OR CAPECITABINE IN COMBINATION WITH PLACEBO.
CAPECITABINE WILL BE ADMINIST
Sponsors
BAYER HEALTHCARE AG,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • WRITTEN INFORMED CONSENT. SUBJECTS MUST BE ABLE TO UNDERSTAND AND BE WILLING TO SIGN THE WRITTEN INFORMED CONSENT FORM. A SIGNED INFORMED CONSENT FORM MUST BE APPROPRIATELY OBTAINED PRIOR TO THE CONDUCT OF ANY TRIAL-SPECIFIC PROCEDURE. • AGE ≥ 18 YEARS. • LIFE EXPECTANCY OF AT LEAST 12 WEEKS (3 MONTHS). • SUBJECT HAS HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED HER2-NEGATIVE ADENOCARCINOMA OF THE BREAST. HER2 STATUS SHOULD BE DETERMINED BY IMMUNOHISTOCHEMISTRY (IHC), FLUORESCENCE IN SITU HYBRIDIZATION (CISH). IF THE SUBJECT´S HER2 STATUS WAS DETERMINED USING A TEST KIT THAT IS NOT APPROVED BY AN APPROPRIATE REGULATORY AUTHORITY (eg., U.S. FDA) AND/OR WAS NOT TESTED USING A VALIDATED ASSAY, HER2 STATUS WILL BE CONFIRMED, WITH THE SUBJECT´S CONSENT, USING AN APPROVED TEST KIT AND/OR VALIDATED ASSAY (SEE APPENDIX 14.3). IF SUCH A SUBJECT DOES NOT CONSENT TO RE-TESTING, THE SUBJECT WILL NOT BE ELIGIBLE FOR THE STUDY. • LOCALLY ADVANCED OR METASTATIC DISEASE. LOCALLY ADVANCED DISEASE MUST NOT BE AMENABLE TO RESECTION WITH CURATIVE INTENT (ie., IS STAGE IIIb OR IIIc, AJCC SIXTH EDITION, SEE APPENDIX 14.7).
Exclusion criteria
Exclusion criteria: • HER2 POSITIVE BREAST CANCER (IHC ≥ 3 +, POSITIVE FISH, OR POSITIVE CISH); EQUIVOCAL OR UNKNOWN HER2 STATUS. SUBJECTS WITH EQUIVOCAL OR UNKNOWN HER2 STATUS MAY CONSENT TO HAVING THEIR HER2 STATUS DETERMINED BY AN APPROVED TEST KIT AND/OR VALIDATED ASSAY (SEE APPENDIX 14.3.) • UNKNOWN HORMONE RECEPTOR STATUS (ESTROGEN AND PROGESTERONE RECEPTOR). • SUBJECTS WHO HAVE RECEIVED NO PRIOR TAXANE AND ANTHRACYCLINE FOR THE TREATMENT OF BREAST CANCER (EITHER IN ADJUVANT, NEO-ADJUVANT OR METASTATIC SETTING). • SUBJECT CONSIDERED BY THE TREATING INVESTIGATOR TO BE APPROPRIATE CANDIDATES FOR HORMONAL THERAPY AS CURRENT TREATMENT FOR METASTATIC BREAST CANCER ARE EXCLUDED. • SUBJECT WITH LOCALLY ADVANCED DISEASE WHO ARE CONSIDERED BY THE TREATING INVESTIGATOR TO BE APPROPRIATE CANDIDATES FOR RADIATION THERAPY AS CURRENT TREATMENT FOR LOCALLY ADVANCED BREAST CANCER ARE EXCLUDED. • SUBJECTS WITH SYMPTOMATIC BRAIN METASTASES. SUBJECTS WITH NEUROLOGICAL SYMPTOMS OR KNOWN BRAIN METASTASIS MUST UNDERGO A CONTRAST CT SCAN OR MRI OF THE BRIAN TO EXCLUDE ACTIVE BRAIN METASTASIS.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Poland, Russian Federation, South Africa, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed