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Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01720602
First received: October 31, 2012
Last updated: November 4, 2016
Last verified: November 2016
Results First Received: October 30, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: vorinostat
Drug: anastrozole
Drug: letrozole
Drug: exemestane
Procedure: positron emission tomography
Radiation: F-18 16 alpha-fluoroestradiol
Radiation: fludeoxyglucose F 18
Other: laboratory biomarker analysis

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Vorinostat, AI Therapy)

Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.

vorinostat: Given PO

anastrozole: Given PO

letrozole: Given PO

exemestane: Given PO

positron emission tomography: Correlative studies

F-18 16 alpha-fluoroestradiol: Correlative studies

fludeoxyglucose F 18: Correlative studies

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Vorinostat, AI Therapy)
STARTED   15 
COMPLETED   10 
NOT COMPLETED   5 
Adverse Event                3 
Progressive disease on therapy                2 



  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.
No text entered.

Reporting Groups
  Description
Treatment (Vorinostat, AI Therapy)

Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.

vorinostat: Given PO

anastrozole: Given PO

letrozole: Given PO

exemestane: Given PO

positron emission tomography: Correlative studies

F-18 16 alpha-fluoroestradiol: Correlative studies

fludeoxyglucose F 18: Correlative studies

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Vorinostat, AI Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      7  46.7% 
>=65 years      8  53.3% 
Gender 
[Units: Participants]
Count of Participants
 
Female      15 100.0% 
Male      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST   [ Time Frame: 8 weeks ]

2.  Primary:   Response Rate According to RECIST   [ Time Frame: 8 weeks ]

3.  Secondary:   Duration of Response   [ Time Frame: Up to 5 years ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


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


Results Point of Contact:  
Name/Title: Hannah Linden, MD
Organization: University of Washington
phone: 206-288-6989
e-mail: hmlinden@u.washington.edu



Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01720602     History of Changes
Other Study ID Numbers: 7841
NCI-2012-02004 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA015704 ( U.S. NIH Grant/Contract )
Study First Received: October 31, 2012
Results First Received: October 30, 2014
Last Updated: November 4, 2016