A Two-Part Adaptive, Randomized Trial of Ridaforolimus in Combination With Dalotuzumab Compared to Exemestane or Compared to Ridaforolimus or Dalotuzumab Monotherapy in Estrogen Receptor Positive Breast Cancer Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 115
- Primary Endpoint
- Progression free survival (PFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part A: 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.
Intervention: ridaforolimus + dalotuzumab (Drug)
Part A: exemestane
Exemestane 25 mg daily; single-agent therapy.
Intervention: exemestane (Drug)
Part B: 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.
Intervention: ridaforolimus + dalotuzumab (Drug)
Part B: 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.
Intervention: ridaforolimus (Drug)
Part B: dalotuzumab
Dalotuzumab intravenous infusion 10 mg/kg weekly; single-agent therapy. With the implementation of Amendment 3, this study arm will not be opened.
Intervention: dalotuzumab (Drug)
Outcomes
Primary Outcomes
Progression free survival (PFS)
Time Frame: 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 Outcomes
- Overall survival (OS)(Every 3 months after participants go off active treatment)
- Objective response rate (ORR)(Assessed every 8 weeks until documentation of disease progression or death.)