A Two-Part, 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 - MK8669-041-00

MERCK & CO., INC.0 个研究点目标入组 115 人开始时间: 2010年9月28日最近更新: 2019年11月25日

研究概览

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•Patient has diagnosis of breast cancer that is metastatic or locally advanced and is estrogen receptor positive and HER-2 negative • Patient is post-menopausal • Patient`s cancer has recurred or progressed after prior treatment with a non-steroidal aromatase inhibitor (anastrozole or letrozole) in the adjuvant or metastatic setting and patient has received at least one line of endocrine therapy for metastatic disease OR the patient`s cancer has recurred within 6 months of the last dose of anastrozole or letrozole • An archival tumor specimen is available • Patient has a performance status of 1 or less on the ECOG (Eastern Cooperative Oncology Group) performance scale
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patient is receiving any other systemic tumor therapy • Patient has previously received rapamycin or rapamycin analogs • Patient has received prior treatment with IGF-1R inhibitors, PI3K inhibitors, or other experimental agents that target the PI3K, AKT, or mTOR pathways • Patient has an active infection that requires antibiotics • Patient has significant or uncontrolled cardiovascular disease • Patient has poorly controlled Type 1 or 2 diabetes mellitus

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