None listed
Conditions
Interventions
APPROXIMATELY 150 PATIENTS WILL BE ENROLLED TO THIS STUDY. PATIENTS WILL BE RANDOMIZED 1:1 TO EITHER:
• ARM A: RIDAFOROLIMUS 10-MG* QDX5, DALOTUZUMAB 10 MG/KG/WEEK AND EXEMESTANE 25MG DAILY (R/D/E)
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. FEMALE PATIENTS WITH A HISTOLOGICALLY CONFIRMED DIAGNOSIS OF BREAST CANCER THAT IS METASTATIC OR LOCALLY ADVANCED (LOCALLY ADVANCED TUMORS MUST NOT BE AMENABLE TO SURGERY OR RADIATION THERAPY WITH CURATIVE INTENT) WITH THE FOLLOWING PATHOLOGICAL CHARACTERISTICS DETERMINED LOCALLY: • ESTROGEN RECEPTOR POSITIVE AS DETERMINED BY LOCAL INSTITUTIONAL LABORATORY CRITERIA FOR ESTROGEN RECEPTOR POSITIVITY. AT A MINIMUM, ER+ MUST BE DEFINED AS ≥ 1 PERCENT TUMOR CELLS POSITIVE BY IMMUNOHISTOCHEMISTRY, IRRESPECTIVE OF INTENSITY (GOLDHIRSCH 2009). • HER-2 NEGATIVE AS DETERMINED BY LOCAL INSTITUTIONAL LABORATORY STANDARDS (FLUORESCENCE IN SITU HYBRIDIZATION [FISH] NEGATIVE OR LESS THAN 3+ BY IMMUNOHISTOCHEMISTRY). • KI67 LABELING INDEX GREATER THAN OR EQUAL TO 15% (KI67 15%) AS DETERMINED BY THE CENTRAL LABORATORY. AN ARCHIVAL TUMOR SPECIMEN OF ADEQUATE QUALITY AND QUANTITY FOR CENTRAL KI67 DETERMINATION IS REQUIRED. • TUMOR SAMPLES: DETERMINATION OF KI67, ER AND HER-2 STATUS SHOULD BE DETERMINED FROM THE PATIENT´S ARCHIVED PRIMARY TUMOR WHENEVER POSSIBLE. HOWEVER, IF AN ARCHIVED SAMPLE OF THE PATIENT´S PRIMARY TUMOR IS UNAVAILABLE OR IS DEEMED INSUFFICIENT FOR BIOMARKER TESTING THE ARCHIVED METASTATIC TUMOR SAMPLE SHOULD BE USED IF AVAILABLE. . FIVE (5) TO 10 ADDITIONAL SLIDES FROM THE TUMOR SAMPLE ARE REQUIRED IN ORDER TO CONDUCT THE STUDY´S TERTIARY OBJECTIVES, (PLEASE SEE THE PROCEDURES MANUAL FOR THE PREPARATION AND SHIPMENT OF PARAFFIN SAMPLES)
Exclusion criteria
Exclusion criteria: 1. PATIENT IS RECEIVING ANY OTHER CONCURRENT SYSTEMIC TUMOR THERAPY, INCLUDING HORMONAL AGENTS AND HER-2 INHIBITORS. • BISPHOSPHONATES AND DENOSUMAB FOR THE TREATMENT OF BONE METASTASES ARE ALLOWED, IF THEY WERE INITIATED PRIOR TO RANDOMIZATION. 2. PATIENT IS CURRENTLY PARTICIPATING OR HAS PARTICIPATED IN A STUDY WITH AN INVESTIGATIONAL COMPOUND OR DEVICE WITHIN 30 DAYS OF INITIAL DOSING WITH STUDY DRUG. 3. PATIENT HAS PREVIOUSLY RECEIVED RAPAMYCIN OR RAPAMYCIN ANALOGS, INCLUDING RIDAFOROLIMUS, TEMSIROLIMUS, OR EVEROLIMUS. 4. PATIENT HAS RECEIVED PRIOR TREATMENT WITH IGF-1R INHIBITORS, PI3K INHIBITORS, OR OTHER EXPERIMENTAL AGENTS THAT TARGET PI3K, AKT, OR MTOR PATHWAY. 5. PATIENT IS RECEIVING CHRONIC CORTICOSTEROIDS ADMINISTERED AT DOSES GREATER THAN THOSE USED FOR NORMAL REPLACEMENT THERAPY. 6. PATIENT IS PREGNANT AND/OR BREASTFEEDING. 7. PATIENT WHO HAS HAD CHEMOTHERAPY, RADIOTHERAPY, OR BIOLOGICAL THERAPY WITHIN 4 WEEKS [(6 WEEKS FOR NITROSOUREAS, MITOMYCIN C, OR BEVACIZUMAB AND 2 WEEKS FOR HORMONAL THERAPY AND KINASE INHIBITORS)] PRIOR TO ENTERING THE STUDY OR WHO HAS NOT RECOVERED FROM ADVERSE EVENTS FROM PRIOR TREATMENT TO AT LEAST GRADE 1 OR BASELINE. PLEASE NOTE: THE USE OF LIMITED FIELD RADIATION THERAPY FOR PAIN MANAGEMENT IS ALLOWED
Countries
Peru
Contacts
Public ContactRodolfo Hernan Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed