Clinical trial NCT00258349 (phase 1/phase 2, status: completed)
Conditions: breast cancer, male breast cancer, recurrent breast cancer, stage iiib breast cancer, stage iiic breast cancer, stage iv breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C50.021, C50.022, C50.029, C50.121, C50.122, C50.129, C50.621, 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, 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: vorinostat, trastuzumab
SMILES: ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active or ongoing infection

          -  No history of allergic reaction to compounds of similar chemical or biologic
             composition to vorinostat or other agents used in study

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other uncontrolled illness

          -  More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin; 1
             week for capecitabine) and recovered

          -  More than 3 weeks since prior radiotherapy and recovered

          -  Recovered from prior therapy

          -  At least 2 weeks since prior valproic acid

          -  More than 4 weeks since prior investigational agents

          -  More than 4 weeks since prior lapatinib ditosylate

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  Measurable disease, defined as >= 1 unidimensionally measurable lesion > 20 mm by
             conventional techniques or > 10 mm by spiral CT scan

          -  No other concurrent investigational agents

          -  Concurrent bisphosphonates allowed provided therapy was initiated prior to study
             treatment

          -  No other concurrent anticancer therapy

          -  Recurrent or progressive disease while receiving prior trastuzumab (Herceptin) (with
             or without chemotherapy) OR relapsed within 3 months of last dose of prior adjuvant
             trastuzumab for metastatic disease

          -  Histologically confirmed breast cancer

          -  Must overexpress HER-2 gene

          -  Metastatic or chest wall recurrent disease

          -  Site of measurable disease must not have been irradiated (except chest wall recurrence
             treated with adjuvant radiation therapy)

          -  No untreated brain metastases

          -  Previously treated brain metastasis responsive to radiotherapy and/or surgery allowed
             provided the brain is not the sole site of measurable disease

          -  ECOG 0-2

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Hemoglobin >= 9 g/dL

          -  AST and ALT =< 2 times upper limit of normal

          -  Bilirubin =< 1.5 mg/dL (3 mg/dL in the presence of Gilbert's disease provided direct
             bilirubin is normal)

          -  Creatinine =< 1.5 mg/dL

          -  LVEF normal by nuclear scan or echocardiogram

          -  No evidence of PR prolongation or AV block by EKG

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia