Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Re-expression of ER in Triple Negative Breast Cancers

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborators:
Novartis
Eisai Inc.
Information provided by (Responsible Party):
Ruth O'Regan, Emory University
ClinicalTrials.gov Identifier:
NCT01194908
First received: September 1, 2010
Last updated: January 18, 2015
Last verified: January 2015
Results First Received: January 18, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Breast Tumors
Breast Neoplasms
Intervention: Drug: Decitabine, LBH589, 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
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
Arm A

Patients treated with decitabine and LBH589

Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2

Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2

Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2

Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2

Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2

Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2


Participant Flow:   Overall Study
    Arm A  
STARTED     5  
COMPLETED     5  
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.
No text entered.

Reporting Groups
  Description
Arm A

Patients treated with decitabine and LBH589

Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2

Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2

Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2

Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2

Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2

Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2


Baseline Measures
    Arm A  
Number of Participants  
[units: participants]
  5  
Age, Customized  
[units: participants]
 
30-39 years     1  
40-49 years     2  
50-59 years     2  
Gender  
[units: participants]
 
Female     5  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures
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1.  Primary:   To Determine the Maximum Tolerated Dose of Decitabine and LBH589 Given in Combination in Patients With Metastatic or Locally Advanced Metastatic Breast Cancers   [ Time Frame: Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks. ]

2.  Secondary:   To Determine the Safety of Tamoxifen in Combination With Decitabine and LBH589   [ Time Frame: Patients will undergo an evaluation for extent of disease 8 weeks from starting study drugs and every 8 weeks (2 cycles) while on study. ]


  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: Ruth O'Regan, MD
Organization: Emory University School of Medicine
phone: 404-778-4824
e-mail: roregan@emory.edu


No publications provided


Responsible Party: Ruth O'Regan, Emory University
ClinicalTrials.gov Identifier: NCT01194908     History of Changes
Other Study ID Numbers: IRB00029718, WCI1696-09
Study First Received: September 1, 2010
Results First Received: January 18, 2015
Last Updated: January 18, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration