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
- Conditions
- Estrogen receptor positive breast cancer
- Registration Number
- EUCTR2010-019867-13-GB
- Lead Sponsor
- Merck Sharp & Dohme Corp.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 115
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method