Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00258349
First received: November 22, 2005
Last updated: May 29, 2014
Last verified: October 2013
Results First Received: August 28, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: vorinostat
Drug: trastuzumab

  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
The phase I portion of the study was activated on August 23, 2006, and completed on June 28, 2007. The phase II portion of the study then was activated, and suspended on October 4, 2007, terminated on August 27, 2009, with a final accrual of 16 patients by ECOG institutes.

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 +Trastuzumab Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.

Participant Flow:   Overall Study
    Vorinostat +Trastuzumab  
STARTED     16  
HER2-positive by Central Review     10  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Vorinostat +Trastuzumab Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.

Baseline Measures
    Vorinostat +Trastuzumab  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ± Standard Deviation
  54.1  ± 10.3  
Gender  
[units: participants]
 
Female     16  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy ]

2.  Secondary:   Time to Progression   [ Time Frame: Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy ]

3.  Secondary:   Overall Survival   [ Time Frame: Survival was assessed every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00258349     History of Changes
Other Study ID Numbers: NCI-2009-00503, NCI-2009-00503, CDR0000449963, E1104, E1104, U10CA021115
Study First Received: November 22, 2005
Results First Received: August 28, 2012
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration