A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

NCT01194427 | Terminated Phase 2 Results

• 2 other identifiers: J09144NA_00033768
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.

Conditions

Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Invasive Breast Cancer

Keywords

Preoperative; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Changes in Markers of Proliferation Prior to and After Study Drug Administration

  To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.

  Baseline and 14 days

Study Arms (1)

Vorinostat and Tamoxifen

EXPERIMENTAL

Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.

Drug: Vorinostat and Tamoxifen

Interventions

Vorinostat and Tamoxifen DRUG

vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days

Also known as: Zolinza

Vorinostat and Tamoxifen

Eligibility Criteria

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

You may qualify if:

• Stage I-III invasive breast cancer
• Awaiting surgery or neoadjuvant treatment
• ECOG performance status 0, 1 or 2
• Adequate organ function
• Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)

You may not qualify if:

• Prior or current treatment of any kind for the current breast cancer
• Current use of any other investigational drugs
• Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vorinostat; Tamoxifen

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; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Unable to recruit participants to complete the study.

Results Point of Contact

• Title: Dr. Vered Stearns
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

vstearn1@jhmi.edu

4432876489

Study Officials

• Vered Stearns, M.D.

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: September 3, 2010
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 17, 2013
• Results First Posted: May 17, 2013

Record last verified: 2013-05

Locations

US (1)