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Breast Cancer

Vorinostat for Stage IV Breast Cancer (6856)
A Pilot Study of Vorinostat (Zolinza) to Restore Sensitivity to Aromatase Inhibitor Therapy
Status Conditions Phase Study ID
Closed Recurrent Breast Cancer
Stage IV Breast Cancer
Male Breast Cancer
Not specified 6856

RATIONALE: Vorinostat may may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help aromatase inhibitor therapy work better by making tumor cells more sensitive to the drug. PURPOSE: This clinical trial studies vorinostat in treating patients with stage IV breast cancer receiving aromatase inhibitor therapy.

Hannah Linden, MD
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No



  • Histologically or cytologically proven diagnosis of breast cancer
  • Stage IV disease
  • Patient has previously derived clinical benefit from AI or other endocrine therapy, but is no longer deriving benefit to AI therapy in the opinion of the treating investigator; patients need to stop the AI for at least one week prior to starting vorinostat treatment on this protocol
  • At least one site of measurable disease, as defined by the modified RECIST Criteria
  • ECOG performance status 0-2
  • Female patient is either post menopausal, free from menses for >= 2 years, surgically sterilized or willing to use 2 barrier methods of contraception (such as IUD, diaphragm, condom) to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study
  • Female patient of childbearing potential has a negative serum or urine pregnancy test within 7 days prior to receiving the first dose of vorinostat
  • Female patient that is pre-menopausal must be on ovarian suppression therapy
  • Male patient agrees to use two barrier methods of contraception or abstain from intercourse for the duration of the study
  • Absolute neutrophil count (ANC) >= 1,500 /mcL
  • Platelets >= 100,000 / mcL
  • Hemoglobin >= 9 g/dL
  • Prothrombin Time or INR =< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation
  • Partial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation
  • Potassium and magnesium levels within normal limits
  • Calculated creatinine clearance >= 30 mL/min
  • Serum total bilirubin =< 1.5 X ULN
  • AST (SGOT) and ALT (SGPT) =< 2.5 X ULN
  • Alkaline Phosphatase =< 2.5 X ULN
  • Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent
  • Patient has a life expectancy of at least 12 weeks
  • Patient is willing to continue on same AI therapy
  • Patient agrees to participate in imagining Protocol 7184 and is separately consented
Exclusions (conditions that would prevent participation in this study)


  • Patient has not derived clinical benefit from any previous hormonal therapy (e.g. tamoxifen or aromatase inhibitor)
  • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug(s) other than the imaging protocol 7184
  • Patient has received an ER blocking therapy (selective estrogen receptor modulating or downregulating SERM or SERD i.e. tamoxifen or fulvestrant) within the past 6 weeks
  • Patient had prior treatment with an HDAC inhibitor (e.g., romidespin [Depsipeptide], NSC-630176, MS 275, LAQ-824, belinostat [PXD-101], LBH589, MGCD0103, CRA024781, etc); patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study; patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period
  • Patient is on any systemic steroids that have not been stabilized to the equivalent of =<10 mg/day prednisone during the 30 days prior to the start of the study drugs
  • Patient has known hypersensitivity to the components of study drug or its analogs
  • Patients with uncontrolled brain metastases
  • NYHA Class III or IV congestive heart failure, myocardial infarction within the previous 6 months, QTc > 0.47 seconds, or uncontrolled arrhythmia.
  • Type I Diabetes Mellitus; patients with Type II Diabetes Mellitus will be included as long as their glucose can be controlled to under 200 mg/dL
  • Patient is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study
  • Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years or are considered by their physician to be at less than 30% risk of relapse
  • Patients with known active viral hepatitis
  • Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate
Last Updated
April 06, 2012
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.