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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE March 25, 2010
First Posted Date  ICMJE September 3, 2010
Results First Submitted Date  ICMJE March 18, 2013
Results First Posted Date  ICMJE May 17, 2013
Last Update Posted Date May 17, 2013
Study Start Date  ICMJE March 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • Invasive Breast Cancer
Intervention  ICMJE Drug: Vorinostat and Tamoxifen
vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days
Other Name: Zolinza
Study Arms  ICMJE Experimental: Vorinostat and Tamoxifen
Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Intervention: Drug: Vorinostat and Tamoxifen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 18, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2010)
56
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01194427
Other Study ID Numbers  ICMJE J09144
NA_00033768 ( Other Identifier: Johns Hopkins )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Vered Stearns, M.D. Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP