Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ridaforol...
Eligibility Criteria
Inclusion
- Inclusion Criteria The prospective participant must meet, at least, all of the criteria below to be eligible for study participation.
- The participant:
- 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 If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.
- The participant:
- 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.
Exclusion
Key Trial Info
Start Date :
September 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2013
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01234857
Start Date
September 17 2010
End Date
October 15 2013
Last Update
May 31 2017
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