None listed
Conditions
Interventions
Patients will be randomly assigned with equal allocation to one of the treatment arms below:
a. Everolimus in combination with exemestane
b. Everolimus monotherapy
c. Capecitabine monotherapy
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Women with locally advanced, recurrent, or metastatic breast cancer.Locally advanced breast cancer is not amenable to curative treatment by surgery or radiotherapy. 2.Histological or cytological confirmation of ER+breast cancer 3.Postmenopausal women. Postmenopausal status is defined either by: -Age ≥18 with prior bilateral oophorectomy -Age ≥60 years-Age<60 years with amenorrhea for at least 12 months and both follicle-stimulating hormone (FSH) and estradiol levels are in postmenopausal range(according to the local laboratory) 4Recurrence or progression on prior AIs is defined as: -Recurrence while on, or within one year (365 days) of end of adjuvant treatment with an aromatase inhibitor OR -Progression while on, or within one month (30 days) of the end of, prior treatment with an aromatase inhibitor for ABC 5Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to randomization 6Patients must have either: -Measurable disease defined as at least one lesion ≥10 mm by CT or MRI that can be accurately measured in at least one dimension(CT scan slice thickness ≤5 mm) OR -Bone lesions: lytic or mixed in the absence of measurable disease as defined above Notes: -Lymph nodes have to be 15 mm in short axis to be considered measurable.-If bone lesions have been previously irradiated, at least one lesion must have clearly progressed since the radiotherapy by CT,MRI or x-ray for trial entry
Exclusion criteria
Exclusion criteria: 1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive), based on the most recent test. Note: Patients with IHC 2+ must have a negative in situ hybridization test. 2. Patients who received more than one chemotherapy line for ABC 3. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis (e.g. pleural effusion, ascites etc.) 4. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritonavir, Telithromycin) continuously for at least 7 days during any time period in the last 2 weeks prior to randomization 5. Patients being treated with drugs recognized as being strong or moderate inhibitors of the isoenzyme CYP2D6 (Fluoxetine, Paroxetine, Quinidine, Buproprion, Duloxetine, Diphenhydramine, Thioridazine, Amiodarone, Cimetidine, Sertraline) or inducers (Dexamethasone, Rifampin) within the last five days prior to randomization 6. Patients being treated with drugs recognized as being strong or moderate inhibitors of the isoenzyme CYP2C9 (Fluconazole, Miconazole, Sulfaphenazole, Amiodarone, Valproic Acid) or inducers (Secobarbital, Rifampin) within the last five days prior to randomization.
Countries
Arabia Saudi, Argentina, Australia, Belgium, Brazil, Denmark, Egypt, Hungary, India, Ireland, Lebano, Malasya, Peru, Russian Federation, Spain, Sweden, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactJuan Reyes
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed