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

NCT01695057 | Withdrawn DMC

• 2 other identifiers: 1B-10-10NCI-2012-01612
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Combined PR/ER response

  The proportion of patients who achieve sufficient deacetylation of ER and PR will be estimable with a standard error no greater than +/- 0.05. The proportion of patients who exhibit a sufficient change in ER or PR expression can be estimated with similar precision. In addition, paired t-tests and McNamaraâs test will be used to evaluate whether the effect of vorinostat on deacetylation status or gene expression differs between ER or PR, and linear regression analysis will be used to evaluate the association between deacetylation changes and corresponding expression changes in ER and PR genes.

  21 days

Secondary Outcomes (1)

• Grade 3 or 4 toxicities using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Within 3 days prior to surgery

Study Arms (1)

Treatment (vorinostat and surgery)

EXPERIMENTAL

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

Drug: vorinostat; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

Interventions

vorinostat DRUG

Given PO

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza

Treatment (vorinostat and surgery)

therapeutic conventional surgery PROCEDURE

Undergo surgery

Treatment (vorinostat and surgery)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (vorinostat and surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Study Officials

• Agustin Garcia

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: January 28, 2014

Record last verified: 2014-01