Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer
Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
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
Sites / Locations
- University of Alabama at Birmingham
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Johns Hopkins University
- Eastern Cooperative Oncology Group
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Saint John's Hospital - Healtheast
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- Saint Francis Regional Medical Center
- Woodwinds Health Campus
- Albert Einstein College of Medicine
- Montefiore Medical Center
- Saint Vincent's Hospital and Medical Center of New York
Arms of the Study
Arm 1
Experimental
Arm I
Patients will receive vorinostat by mouth twice a day for 2 weeks. They will also receive a 90-minute infusion of trastuzumab in week 1.