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Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00365599
First received: August 15, 2006
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
Results First Received: February 21, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: suberoylanilide hydroxamic acid (SAHA, Vorinostat)
Drug: tamoxifen citrate (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
Estrogen or progesterone receptor positive advanced breast cancer: Postmenopausal, failed first-line therapy with aromatase inhibitor or recurred within 12 months of adjuvant treatments with aromatase inhibitors; Premenopausal, recurred >12 months after adjuvant tamoxifen or never treated with tamoxifen; Not candidate for aromatase inhibitor

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vorinostat and Tamoxifen Vorinostat and Tamoxifen as outlined in Intervention Descriptions

Participant Flow:   Overall Study
    Vorinostat and Tamoxifen  
STARTED     43  
COMPLETED     43  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Vorinostat and Tamoxifen Vorinostat and Tamoxifen as outlined in Intervention Descriptions

Baseline Measures
    Vorinostat and Tamoxifen  
Number of Participants  
[units: participants]
 		  43  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     37  
>=65 years     6  
Age, Customized  
[units: years]
Median ( Full Range ) 		  56  
  ( 33 to 71 )  
Gender  
[units: participants]
 		 
Female     43  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     43  



  Outcome Measures
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1.  Primary:   Number of Participants With Objective Response (OR)   [ Time Frame: 24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Up to 30 months ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: 4 years, 7 months ]
  Show Outcome Measure 3


  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
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Results Point of Contact:  
Name/Title: Susan Minton, D.O.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-3806
e-mail: susan.minton@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00365599     History of Changes
Other Study ID Numbers: MCC-14662
Study First Received: August 15, 2006
Results First Received: February 21, 2012
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration