A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in Estrogen Receptor Positive Breast Cancer Patients (MK-8669-041 AM3)
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT01234857
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a two-part study that will determine, if: 1) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to exemestane; and 2) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to both ridaforolimus and dalotuzumab as single agents, in participants with breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 115
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: ridaforolimus + dalotuzumab ridaforolimus + dalotuzumab Patients are randomly assigned in a 1:1 ratio to treatment with the ridaforolimus (20 mg daily five days a week)/dalotuzumab (intravenous infusion 10 mg/kg once weekly) combination therapy or cross-over to one of two single-therapy treatments (ridaforolimus alone or dalotuzumab alone). With the implementation of Amendment 3, this study arm will not be opened. Part A: ridaforolimus + dalotuzumab ridaforolimus + dalotuzumab Approximately 15 patients will be enrolled to the ridaforolimus-dalotuzumab combination treatment arm. Subsequent Patients are randomly assigned in a 1:1 ratio to treatment with the ridaforolimus (20 mg daily five days a week)/dalotuzumab (intravenous infusion 10 mg/kg once weekly) combination therapy or cross-over to exemestane single-therapy treatment. Part A: exemestane exemestane Exemestane 25 mg daily; single-agent therapy. Part B: ridaforolimus ridaforolimus Ridaforolimus; 40 mg daily five days a week, single-agent therapy. With the implementation of Amendment 3, this study arm will not be opened. Part B: dalotuzumab dalotuzumab Dalotuzumab intravenous infusion 10 mg/kg weekly; single-agent therapy. With the implementation of Amendment 3, this study arm will not be opened.
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) Assessed every 8 weeks until documentation of disease progression or death. Progression free survival is defined as the time from randomization to progressive disease or death, which ever occurs earlier.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Every 3 months after participants go off active treatment Overall survival is defined as the time from randomization to death due to any cause.
Objective response rate (ORR) Assessed every 8 weeks until documentation of disease progression or death. 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