Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer
Condition: Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: vorinostat; conventional surgery
Intervention description: Given orally, conventional surgery to follow.; Undergo conventional surgery
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo conventional surgical resection of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.
Masking: None (Open Label)
Enrollment: 54.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well vorinostat works in treating women who are
      undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer.
      Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No prior or concurrent hormonal therapy for breast cancer

          -  Histologically confirmed breast cancer, stage I-III disease, scheduled to undergo
             definitive surgery or other primary treatment (e.g., preoperative/neoadjuvant systemic
             treatment) for breast cancer

          -  ECOG 0-2 OR Karnofsky 60-100%

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin normal

          -  AST and ALT ≤ 2.5 times upper limit of normal

          -  PT ≤ 14 seconds

          -  Creatinine normal

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other uncontrolled intercurrent illness

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biologic composition to vorinostat

          -  At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or
             progestin)

          -  Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed

          -  No concurrent birth control pills

          -  No prior radiotherapy to the ipsilateral breast

          -  No prior or concurrent radiotherapy for breast cancer

          -  No prior or concurrent novel therapy for breast cancer

          -  At least 14 days since prior valproic acid or another histone deacetylase inhibitor

          -  No other concurrent investigational agents

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent therapy for this cancer

          -  WBC ≥ 3,000/mm^3

        Exclusion criteria:

          -  Patients must not be recieving any other investigational agents

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to SAHA.

          -  Patients may not be taking valproic acid or another histone deacetylase inhibitor for
             at least 2 weeks prior to initiating SAHA.

          -  Women who are pregnant.