Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer

PRIMARY OBJECTIVE:

I. Determine the safety and tolerability of vorinostat in women undergoing conventional
surgery for newly diagnosed stage I-III breast cancer.

OULINE: This is a multicenter, pilot study.

Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the
final dose of vorinostat, patients undergo surgical resection of the tumor on day 0.

After completion of study treatment, patients are followed for 30 days.

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.