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Re-expression of ER in Triple Negative Breast Cancers

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ClinicalTrials.gov Identifier: NCT01194908
Recruitment Status : Terminated (Slow accrual)
First Posted : September 3, 2010
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Collaborators:
Novartis
Eisai Inc.
Information provided by (Responsible Party):
Ruth O'Regan, Emory University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Breast Tumors
Breast Neoplasms
Intervention: Drug: Decitabine, LBH589, 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
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

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 
Overall Participants Analyzed 
[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

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

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
No text entered.


  More Information

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



Responsible Party: Ruth O'Regan, Emory University
ClinicalTrials.gov Identifier: NCT01194908     History of Changes
Other Study ID Numbers: IRB00029718
WCI1696-09 ( Other Identifier: Other )
First Submitted: September 1, 2010
First Posted: September 3, 2010
Results First Submitted: January 18, 2015
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015