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Trial record 2 of 4 for:    vorinostat+tamoxifen+breast cancer

Phase II Trial of SAHA & Tamoxifen for Patients With 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: NCT00365599
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : March 26, 2012
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: suberoylanilide hydroxamic acid (SAHA, Vorinostat)
Drug: tamoxifen citrate (Tamoxifen)
Enrollment 43
Recruitment Details Estrogen or progesterone receptor positive advanced breast cancer: Postmenopausal, failed first-line therapy with aromatase inhibitor or recurred within 12 months of adjuvant treatments with aromatase inhibitors; Premenopausal, recurred >12 months after adjuvant tamoxifen or never treated with tamoxifen; Not candidate for aromatase inhibitor
Pre-assignment Details  
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description Vorinostat and Tamoxifen as outlined in Intervention Descriptions
Period Title: Overall Study
Started 43
Completed 43
Not Completed 0
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description Vorinostat and Tamoxifen as outlined in Intervention Descriptions
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
<=18 years
0
   0.0%
Between 18 and 65 years
37
  86.0%
>=65 years
6
  14.0%
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants
56
(33 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
43
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
1.Primary Outcome
Title Number of Participants With Objective Response (OR)
Hide Description The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description:
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
8
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame Up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description:
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: months
10.3
(8.1 to 12.4)
3.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame 4 years, 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description:
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
4
Time Frame 4 years, 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vorinostat and Tamoxifen
Hide Arm/Group Description Vorinostat and Tamoxifen as outlined in Intervention Descriptions
All-Cause Mortality
Vorinostat and Tamoxifen
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Vorinostat and Tamoxifen
Affected / at Risk (%) # Events
Total   4/43 (9.30%)    
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/43 (2.33%)  1
Hemorrhage/Bleeding  1 [2]  1/43 (2.33%)  1
Neutrophils/granulocytes (ANC/AGC)  1 [3]  1/43 (2.33%)  1
Platelets  1 [4]  1/43 (2.33%)  1
Gastrointestinal disorders   
Anorexia  1 [5]  1/43 (2.33%)  1
Metabolism and nutrition disorders   
Sodium, serum-low (hyponatremia)  1 [1]  1/43 (2.33%)  1
Vascular disorders   
Thrombosis/thrombus/embolism  1 [6]  2/43 (4.65%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 3, possibly related
[2]
Grade 2, possibly related
[3]
Grade 3, related
[4]
Grade 4, related
[5]
Grade 2, probably related
[6]
Grade 4, possibly related
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vorinostat and Tamoxifen
Affected / at Risk (%) # Events
Total   33/43 (76.74%)    
Blood and lymphatic system disorders   
Leukopenia - Grade 2  1 [1]  4/43 (9.30%)  9
Lymphopenia - Grade 2  1  5/43 (11.63%)  16
Lymphopenia - Grade 3  1  6/43 (13.95%)  6
Neutropenia - Grade 2  1  5/43 (11.63%)  5
Neutropenia - Grade 3  1  7/43 (16.28%)  7
Thrombocytopenia - Grade 2  1  4/43 (9.30%)  7
Thrombocytopenia - Grade 3  1 [2]  3/43 (6.98%)  3
Gastrointestinal disorders   
Anorexia/weight loss - Grade 2  1  7/43 (16.28%)  11
Anorexia/weight loss - Grade 3  1  4/43 (9.30%)  4
Diarrhea - Grade 2  1 [3]  7/43 (16.28%)  8
Nausea - Grade 2  1  8/43 (18.60%)  13
General disorders   
Fatigue - Grade 2  1  8/43 (18.60%)  16
Fatigue - Grade 3  1  7/43 (16.28%)  8
Metabolism and nutrition disorders   
Hepatic dysfunction (alanine aminotransferase/aspartate aminotransferase [ALT/AST]) - Grade 2  1 [3]  3/43 (6.98%)  8
Hyperglycemia - Grade 2  1 [1]  5/43 (11.63%)  11
Respiratory, thoracic and mediastinal disorders   
Deep vein thrombosis/pulmonary embolish (DVT/PE) - Grade 4  1  3/43 (6.98%)  3
Skin and subcutaneous tissue disorders   
Alopecia - Grade 2  1  4/43 (9.30%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
(There were also 2 Grade 3 events, below the Frequency Threshold for reporting)
[2]
(There was also one Grade 4 event, below the Frequency Threshold for reporting)
[3]
(There was also one Grade 3 event, below the Frequency Threshold for reporting)
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: Susan Minton, D.O.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3806
EMail: susan.minton@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00365599    
Other Study ID Numbers: MCC-14662
First Submitted: August 15, 2006
First Posted: August 17, 2006
Results First Submitted: February 21, 2012
Results First Posted: March 26, 2012
Last Update Posted: November 21, 2014