None listed
Conditions
Interventions
THIS 3-ARM OPEN-LABEL TRIAL WILL RANDOMIZE SUBJECTS TO ONE OF THE THREE TREATMENT ARMS AS FOLLOWS (FIGURE 1):
• TREATMENT GROUP A: LAPATINIB 1000 mg PO ONCE DAILY PLUS TRASTUZUMAB (LOADING DOSE OF
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. SIGNED WRITTEN INFORMED CONSENT 2. POST-MENOPAUSAL FEMALE SUBJECTS ≥ 18 YEARS OF AGE. POSTMENOPAUSALAS DEFINED BY ANY OF THE FOLLOWING: . AGE > 60 YEARS . AGE ≥ 45 YEARS WITH AMENORRHEA > 12 MONTHS WITH AN INTACT UTERUS . HAVING UNDERGONE A BILATERAL OOPHORECTOMY OR RADIATION CASTRATION WITH AMENORRHEA FOR AT LEAST 6 MONTHS . FSH AND ESTRADIOL LEVELS IN POSTMENOPAUSAL RANGE (UTILIZING RANGES FROM THE LOCAL LABORATORY FACILITY). IN SUBJECTS WHO HAVE PREVIOUSLY BEEN TREATED WITH AN GnRH/LHRH ANALOGUE, THE LAST INJECTION MUST HAVE BEEN ADMINISTERED > 4 MONTHS PRIOR TO RANDOMIZATION AND MENSES MUST NOT HAVE RESTARED. 3. HISTOLOGICALLY CONFIRMED STAGE IV INVASIVE BREAST CANCER . SUBJECTS MAY HAVE EITHER MEASURABLE OR NON-MEASURABLE DISEASE PER RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST 1.1) [EISENHAUER, 2009]. 4. TUMORS THAT ARE ER+ AND/OR PgR+ BY LOCAL LABORATORY 5. DOCUMENTATION OF HER2 OVEREXPRESSION OR GENE AMPLIFICATION, IN THE INVASIVE COMPONENT OF EITHER THE PRIMARY TUMOR OR METASTATIC DISEASE SITE AS DEFINED AS: . 3+ BY IMMUNOHISTOCHEMISTRY (IHC)
Exclusion criteria
Exclusion criteria: 1. HISTORY OF ANOTHER MALIGNANCY. EXCEPTION: SUBJECTS WHO HAVE BEEN DISEASE-FREE FOR 5 YEARS, OR SUBJECTS WITH A HISTORY OF COMPLETELY RESECTED NON-MELANOMA SKIN CANCER OR SUCESSFULLY TREATED IN SITU CARCINOMA ARE ELEGIBLE. 2. SUBJECTS WITH EXTENSIVE SYMPTOMATIC VISCERAL DISEASE INCLUDING HEPATIC INVOLVEMENT AND PULMOVARY LYMPHANGITIC SPREAD OF TUMOR, OR THE DISEASE IS CONSIDERED BY THE INVESTIGATOR TO BE RAPIDLY PROGRESSING OR LIFE THREATENING (SUBJEXTS WHO ARE INTENDED FOR CHEMOTHERAPY). 3. SUBJECTS WHO RECEIVED PRIOR CHEMOTHERAPY, HORMONAL TEHRAPY, IMMUNOTHERAPY, BIOLOGIC THERAPY, OR ANTI-HER2 THERAPY FOR ADVANCED OR METASTASIC DISEASE. 4. SERIOUS CARDIAC ILLNESS OR MEDICAL CONDITION INCLUDING BUT NOT CONFINED TO: . UNCONTROLLED ARRHYTHMIAS . UNCONTROLLED OR SYMPTOMATIC ANGINA . HISTORY OF CONGESTIVE HEART FAILURE (CHF) . DOCUMENTED MYOCARDIAL INFARCTION < 6 MONTHS FROM STUDY ENTRY 5. KNOWN HISTORY OF, OR CLINICAL EVIDENCE OF, CENTRAL NERVIOUS SYSTEM (CNS) METASTASES OR LEPTOMENINGEAL CARCINOMATOSIS. 6. CURRENT ACTIVE HEPATIC OR BILIARY DISEASE (WITH EXCEPTION OF SUBJECTS WITH GILBERT’S SYNDROME, ASYMPTOMATIC GALLSTONES, LIVER METASTASES OR STABLE CHRONIC LIVER DISEASE PER INVESTIGATOR ASSESSMENT).
Countries
Argentina, Belgium, Brazil, Bulgaria, China, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea South, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kindgdom, United States
Contacts
Public ContactAndres Cesar Martin Bayona
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed