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

Completed · Phase 2

Conditions studied: Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer

In brief

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.

Key facts

Study ID

NCT00262834

Run by

National Cancer Institute (NCI)

People needed

54

Starts

2005-10-01

Expected to finish

2013-05-01

Last updated by the study team

2020-02-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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