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A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

This study has been terminated.
(Difficulty meeting patient accrual goals)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194427
First Posted: September 3, 2010
Last Update Posted: May 17, 2013
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose
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 Intervention Phase
Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Invasive Breast Cancer Drug: Vorinostat and Tamoxifen Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01194427


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

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01194427     History of Changes
Other Study ID Numbers: J09144
NA_00033768 ( Other Identifier: Johns Hopkins )
First Submitted: March 25, 2010
First Posted: September 3, 2010
Results First Submitted: March 18, 2013
Results First Posted: May 17, 2013
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Preoperative
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Vorinostat
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