Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer

University of Southern California

Status

Withdrawn

Conditions

Stage IIIA Breast Cancer

Triple-negative Breast Cancer

Stage II Breast Cancer

Treatments

Drug: vorinostat

Other: laboratory biomarker analysis

Procedure: therapeutic conventional surgery

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01695057

NCI-2012-01612 (Registry Identifier)

1B-10-10

Details and patient eligibility

About

This pilot clinical trial studies vorinostat before surgery in treating patients with triple-negative breast cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving enzyme inhibitor therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed

Full description

PRIMARY OBJECTIVES:

I. To evaluate the ability of histone deacetylase (HDAC) inhibition using suberoylanilide hydroxamic acid (SAHA) (vorinostat) to induce expression of the estrogen receptor (ER) and progesterone receptor (PR) genes in solid human triple negative invasive breast cancer.

OUTLINE:

Patients receive vorinostat 400 mg daily orally (PO) on days 1-21 followed by surgery within 14 days.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Resectable tumor measuring 2cm or more
Histologically documented, newly diagnosed, triple negative invasive breast cancer characterized by 0% immunohistochemistry (IHC) nuclear staining for ER-alpha, 0% IHC nuclear staining for PR-alpha, and no amplification of human epidermal growth factor receptor 2 (HER2)/neu by fluorescent in situ hybridization (FISH) using institutional standard; standard IHC assays for ER and PR use antibodies to ER-alpha and PR-alpha and PR-beta
Southwest Oncology Group (SWOG) performance status of less than or equal to 1
Absolute neutrophil count (ANC) >= 1500/uL
Hemoglobin (Hgb) >= 9 g/dL
Platelets >= 100,000/uL
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN) or =< 5.0 x ULN in patients with liver metastases
Creatinine =< 2.0 mg/dL or calculated creatinine clearance >= 50 ml/min
Albumin >= 3 g/dL
Potassium >= lower limit normal (LLN)
Phosphorous >= LLN
Calcium >= LLN
Magnesium > LLN
Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment
Accessible for treatment and follow-up
Written informed consent prior to study entry

Exclusion criteria

HER2/neu amplification by FISH
Concurrent neoadjuvant anti-cancer treatment with chemotherapy, endocrine therapy, biologically targeted therapy or radiotherapy
Known hypersensitivity to SAHA
Preexisting hepatic impairment or renal impairment
Intent to receive additional neoadjuvant therapy prior to surgery
Concurrent use of an HDAC inhibitor or hydralazine
Known diagnosis of human immunodeficiency virus (HIV) infection
Major surgery < 4 weeks prior to starting study drug
Pregnant or breastfeeding or female of reproductive potential not using an effective method of birth control
Other concurrent severe, uncontrolled infection or intercurrent illness, including but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
Prior antiestrogens (selective estrogen receptor modulator [SERM] or aromatase inhibitors) within 6 months of study entry
Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment