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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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)