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

NCT ID: NCT01695057

Last Updated: 2014-01-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-10-31

Brief Summary

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

Detailed 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.

Conditions

Stage II Breast Cancer; Stage IIIA Breast Cancer; Triple-negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (vorinostat and surgery)

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

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

Given PO

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo surgery

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

vorinostat

Given PO

Intervention Type: DRUG

therapeutic conventional surgery

Undergo surgery

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

L-001079038; SAHA; suberoylanilide hydroxamic acid; Zolinza

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agustin Garcia

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Other Identifiers

NCI-2012-01612

Identifier Type: REGISTRY

Identifier Source: secondary_id

1B-10-10

Identifier Type: -

Identifier Source: org_study_id