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

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ClinicalTrials.gov Identifier: NCT00365599
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : March 26, 2012
Last Update Posted : November 21, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: suberoylanilide hydroxamic acid (SAHA, Vorinostat)
Drug: tamoxifen citrate (Tamoxifen)

  Participant Flow

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
Vorinostat and Tamoxifen Vorinostat and Tamoxifen as outlined in Intervention Descriptions

Participant Flow:   Overall Study
    Vorinostat and Tamoxifen

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Vorinostat and Tamoxifen Vorinostat and Tamoxifen as outlined in Intervention Descriptions

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

  Outcome Measures

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

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

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

  Serious Adverse Events

  Other Adverse Events

  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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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

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

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00365599     History of Changes
Other Study ID Numbers: MCC-14662
First Submitted: August 15, 2006
First Posted: August 17, 2006
Results First Submitted: February 21, 2012
Results First Posted: March 26, 2012
Last Update Posted: November 21, 2014