Clinical trial NCT00736970 (phase 2, status: completed)
Conditions: breast cancer, breast neoplasms
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: ridaforolimus, trastuzumab
SMILES: CO[C@@H]1C[C@H](C[C@@H](C)[C@@H]2CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@@H]3CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@H]3C(=O)O2)OC)CC[C@H]1OP(C)(C)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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