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

Merck Sharp & Dohme Corp.,0 个研究点目标入组 115 人开始时间: 2010年10月8日最近更新: 2019年6月30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 is receiving chronic corticosteroids administered at doses greater than those used for normal replacement therapy
•Paitnet has had chemotherapy, radiotherapy, biological therapy, or hormonal therapy within 4 weeks prior to study start
•Active brain metastasis or leptomeningeal carcinomatosis
•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
•Patient is HIV poisitve, known history of active hepatitis B or C, known psychiatric or substance abuse disorders or not adequately recovered from prior surgical procedure.

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