A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064)
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
Females with a histologically confirmed diagnosis of breast cancer that is metastatic or locally advanced (locally advanced tumors must not be amenable to
surgery or radiation therapy with curative intent) with the following pathological characteristics determined locally: estrogen receptor positive and Human Epidermal Growth Factor Receptor 2 (HER-2) negative, and Ki67 (a tumor marker) ≥ 15% determined by the central study laboratory
Post-menopausal
With advanced breast cancer whose disease was refractory to previous letrozole or anastrozole
Has at least one confirmed measurable metastatic lesion
Has a performance status ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Has a life expectancy of at least 3 months
Adequate organ function
Known allergy to macrolide antibiotics
Has an active infection requiring antibiotics
Significant or uncontrolled cardiovascular disease
Poorly controlled Type 1 or 2 diabetes
Is known to be Human Immunodeficiency Virus (HIV) positive
Has a known history of active hepatitis B or C. Healthy carriers of hepatitis B are not allowed on this study
You may not be if
Is receiving any other concurrent systemic tumor therapy, including
hormonal agents and HER-2 inhibitors
Previously received rapamycin or rapamycin analogs, including
ridaforolimus, temsirolimus, or everolimus
Received prior treatment with Insulin-like Growth Factor 1 Receptor (IGF-1R) inhibitors, Phosphatidylinositol 3-Kinase (PI3K) inhibitors, or
other experimental agents that target PI3K, Protein Kinase B (AKT), or Mammalian Target of Rapamycin (mTOR) pathway
Is receiving chronic corticosteroids administered at doses greater than
those used for normal replacement therapy
Has active brain metastasis or leptomeningeal carcinomatosis; patients
Clareo Health | A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064)
