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Trial record 1 of 4 for:    vorinostat+tamoxifen+breast cancer
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A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01194427
Recruitment Status : Terminated (Difficulty meeting patient accrual goals)
First Posted : September 3, 2010
Results First Posted : May 17, 2013
Last Update Posted : May 17, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Invasive Breast Cancer
Intervention Drug: Vorinostat and Tamoxifen
Enrollment 2
Recruitment Details Patients will be recruited through the breast cancer clinics at each of the participating centers (ie, Johns Hopkins).
Pre-assignment Details Women 18 years or older with a histologically confirmed diagnosis of invasive mammary carcinoma on a core needle biopsy and with adequate organ function who are awaiting a definitive surgical procedure or initiation of neoadjuvant chemotherapy are eligible.
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Changes in Markers of Proliferation Prior to and After Study Drug Administration
Hide Description To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.
Time Frame Baseline and 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Two (2) participants were enrolled; however, due to difficulty in recruitment, we were not able to complete the study. There were not study-specific analyses completed or results to report.
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description:
Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 14 days
Adverse Event Reporting Description Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
 
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
All-Cause Mortality
Vorinostat and Tamoxifen
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Vorinostat and Tamoxifen
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vorinostat and Tamoxifen
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Gastrointestinal disorders   
Anorexia  1  1/2 (50.00%)  1
Diarrhea  1  2/2 (100.00%)  2
Dysgeusia  1  1/2 (50.00%)  1
Flatulence  1  1/2 (50.00%)  1
General disorders   
Fatigue  1  1/2 (50.00%)  1
Nervous system disorders   
Dizziness  1  1/2 (50.00%)  1
Headache  1  1/2 (50.00%)  1
Renal and urinary disorders   
Urinary frequency  1  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Rash acneiform  1  1/2 (50.00%)  1
Vascular disorders   
Hot flashes  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Unable to recruit participants to complete the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Vered Stearns
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 4432876489
EMail: vstearn1@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01194427    
Other Study ID Numbers: J09144
NA_00033768 ( Other Identifier: Johns Hopkins )
First Submitted: March 25, 2010
First Posted: September 3, 2010
Results First Submitted: March 18, 2013
Results First Posted: May 17, 2013
Last Update Posted: May 17, 2013