Clinical trial NCT00379197 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: naltrexone
SMILES: OC1=CC=C2C[C@H]3N(CC=C)CC[C@@]45[C@@H](OC1=C24)C(=O)CC[C@@]35O
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic, hormone-receptor positive breast cancer

          -  Disease that has progressed despite previous systemic hormonal therapy. Hormone
             therapy must be terminated at least 2 weeks prior to study enrollment.

          -  Prior chemotherapy, immunotherapy, or biological therapy is allowed if at least 3
             weeks since last treatment. Patient must recover from the acute toxic effects of the
             treatment prior to study enrollment.

          -  Measurable disease as defined by solid tumor response (RECIST) criteria or
             non-measurable bone disease that is Positron-emission tomography (PET) avid

          -  Karnofsky performance status >70%

          -  Female, age 18 years or older

          -  Adequate organ function within 14 days of study enrollment including the following:

               -  Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
                  (ANC) ≥ 1.5 x 10^9/L, platelets >75 x 10^9/L, and hemoglobin > 8 g/dL

               -  Hepatic: bilirubin ≤ 2 times the upper limit of normal (× ULN), aspartate
                  transaminase (AST) and alanine transaminase (ALT) ≤ 2 × ULN. (AST and ALT ≤ 5 ×
                  ULN is acceptable if liver has tumor involvement)

               -  Renal: creatinine ≤ 2 times the upper limit of normal

          -  Women of childbearing potential are required to use an effective method of
             contraception (ie, a hormonal contraceptive, intrauterine device, diaphragm with
             spermicide, condom with spermicide, or abstinence) during the study and for 3 months
             after the last dose of study drug.

          -  Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

        Exclusion criteria:

          -  Brain metastases unless stable for 1 month or more following radiation therapy.

          -  Pregnant or lactating women. PET-CT is not approved during pregnancy. A negative urine
             or serum pregnancy test is required for all females of child bearing potential within
             7 days prior to study entry. Pregnancy testing is not required for post-menopausal or
             surgically sterilized women.

          -  Use of any short-acting or long-acting opioid medication (including morphine,
             meperidine, oxycodone, hydromorphone, hydrocodone, fentanyl, tramadol) within 10 days
             prior to study enrollment

          -  Pain uncontrolled with the use of non-narcotic drugs (acetaminophen or non-steroidal
             medications)

          -  History of sensitivity to naltrexone

          -  Acute hepatitis or liver failure

          -  Immunosuppressive therapy for patients with autoimmune diseases, organ transplant, or
             other indications