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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:
Collaborator:
Merck
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01194427
First received: March 25, 2010
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Invasive Breast Cancer
Intervention: Drug: Vorinostat and Tamoxifen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients will be recruited through the breast cancer clinics at each of the participating centers (ie, Johns Hopkins).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Women 18 years or older with a histologically confirmed diagnosis of invasive mammary carcinoma on a core needle biopsy and with adequate organ function who are awaiting a definitive surgical procedure or initiation of neoadjuvant chemotherapy are eligible.

Reporting Groups
  Description
Vorinostat and Tamoxifen Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.

Participant Flow:   Overall Study
    Vorinostat and Tamoxifen  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Vorinostat and Tamoxifen Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.

Baseline Measures
    Vorinostat and Tamoxifen  
Number of Participants  
[units: participants]
 		  2  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     2  



  Outcome Measures

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Unable to recruit participants to complete the study.  


Results Point of Contact:  
Name/Title: Dr. Vered Stearns
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
phone: 4432876489
e-mail: vstearn1@jhmi.edu


No publications provided


Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01194427     History of Changes
Other Study ID Numbers: J09144, NA_00033768
Study First Received: March 25, 2010
Results First Received: March 18, 2013
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board