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
Female, 18 years of age or older
Histologically confirmed HER2-positive metastatic breast cancer
Trastuzumab-resistance
Measurable disease, according to RECIST guidelines
ECOG performance status less than or equal to 1
Life expectancy greater than 3 months
No prior treatment with temsirolimus, everolimus, rapamycin, or any other mTOR inhibitor
At least 4 weeks must have lapsed between prior investigational therapy, chemotherapy or radiotherapy, and the first dose of ridaforolimus
Left ventricular ejection greater than or equal to 50%
Adequate cardiovascular function
Adequate hematological, hepatic, and renal function
Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
Negative pregnancy test within 7 days prior to first dose of study drug and must use an approved contraceptive method from screening to 30 days after the last dose of study drug
Availability and patient consent to obtain archival tissue samples
Signed informed consent
You may not be if
Inadequate recovery from any prior surgical procedure or having undergone any major surgery within 2 weeks before trial entry
Grade 1 or Grade 2 hypersensitivity reactions to prior trastuzumab therapy if these reactions prevented further trastuzumab administration
Grade 3 or Grade 4 hypersensitivity reaction to prior trastuzumab
Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
Known allergy to macrolide antibiotics
Pregnant or breast-feeding
Know history of HIV
Diagnosis of brain metastasis or leptomeningeal carcinomatosis within 3 months
Other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
Active infection requiring prescription intervention
Newly diagnosed or poorly controlled Type 1 or 2 diabetes
Other concurrent illness which, in the Investigator's judgment, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
Concurrent treatment with medications that strongly induce or inhibit cytochrome P450.
Any condition that renders patient unable to fully understand and provide informed consent and/or comply with the protocol
Clareo Health | Oral Deforolimus With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer (8669-009)
