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Trial record 1 of 4 for:    vorinostat+tamoxifen+breast cancer
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A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01194427
Recruitment Status : Terminated (Difficulty meeting patient accrual goals)
First Posted : September 3, 2010
Results First Posted : May 17, 2013
Last Update Posted : May 17, 2013
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Invasive Breast Cancer Drug: Vorinostat and Tamoxifen Phase 2

Detailed Description:

Key eligibility criteria include:

  • Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
  • No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
  • No prior or current use of any therapy to treat the current breast cancer.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Vorinostat and Tamoxifen
Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Drug: Vorinostat and Tamoxifen
vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days
Other Name: Zolinza

Primary Outcome Measures :
  1. Changes in Markers of Proliferation Prior to and After Study Drug Administration [ Time Frame: Baseline and 14 days ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01194427

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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme Corp.
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Principal Investigator: Vered Stearns, M.D. Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT01194427    
Other Study ID Numbers: J09144
NA_00033768 ( Other Identifier: Johns Hopkins )
First Posted: September 3, 2010    Key Record Dates
Results First Posted: May 17, 2013
Last Update Posted: May 17, 2013
Last Verified: May 2013
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action