None listed
Conditions
Interventions
Group 1 Type of group
Ridaforolimus 20 mg once daily (QD) five days a week, with the possibility of escalation to 30 mg once daily (QD) after the first cycle and dalotuzumab intravenous infusion 10 mg/kg once weekly (QW). Treatment will continue until disease progression.
Group name:Group 2 Type of group
Exemestane 25 mg daily (QD). Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Has a confirmed diagnosis of breast cancer that is metastatic or locally advanced and is estrogen receptor positive and human epidermal growth factor receptor 2 (HER-2) negative ; • Is post-menopausal; • Is at least 18 years of age; • Has a life expectancy of at least 3 months; • Has had a recurrence or progression of cancer after prior treatment and patient has received at least one line of endocrine therapy for metastatic disease, OR the patient´s cancer has recurred within 6 months after the last dose of anastrozole or letrozole; • Has an available archival tumor specimen; • Has voluntarily agreed to participate by signing informed consent.
Exclusion criteria
Exclusion criteria: • Is receiving any other systemic tumor therapy; • Has previously received rapamycin or rapamycin analogs; • Has received prior treatment with insulin-like growth factor 1 receptor (IGF-1R) inhibitors, phosphoinositide 3-kinase (PI3K) inhibitors, or other experimental agents that target the PI3K, protein kinase B (AKT), or mammalian target of rapamycin (mTOR) pathways; • Has known allergy to macrolide antibiotics; • Has an active infection that requires antibiotics; • Has significant or uncontrolled cardiovascular disease; • Has poorly controlled Type 1 or 2 diabetes mellitus; • Is known to be human immunodeficiency virus (HIV) positive; • Has a known history of active Hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Progression free survival is defined as the time from randomization to progressive disease or death, which ever occurs earlier. Measure:Progression free survival (PFS) Timepoints:Assessed every 8 weeks until documentation of disease progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Objective response rate (ORR) will be estimated by the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Measure:Objective response rate (ORR) Timepoints:Assessed every 8 weeks until documentation of disease progression or death. ; Outcome name:Overall survival is defined as the time from randomization to death due to any cause. Measure:Overall survival (OS) Timepoints:Every 3 months after participants go off active treatment | — |
Countries
Belgium, Denmark, France, Germany, Ireland, Italy, Spain, Sweden, United Kindgdom
Contacts
Public ContactJORGE TIMOTEO
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed