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.