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

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: NCT01720602
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : November 6, 2014
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Vorinostat, AI Therapy)
Hide Arm/Group Description

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
Period Title: Overall Study
Started 15
Completed 10
Not Completed 5
Reason Not Completed
Adverse Event             3
Progressive disease on therapy             2
Arm/Group Title Treatment (Vorinostat, AI Therapy)
Hide Arm/Group Description

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
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  46.7%
>=65 years
8
  53.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST
Hide Description

A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.

Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vorinostat, AI Therapy)
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients
60
(35 to 81)
2.Primary Outcome
Title Response Rate According to RECIST
Hide Description

A 90% score (Wilson) confidence interval will be computed for the response rate.

Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vorinostat, AI Therapy)
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients
60
(35 to 81)
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response will be summarized for responders.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vorinostat, AI Therapy)
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: weeks
29.6
(24.9 to 91.4)
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival is assessed relative to the start of the study therapy. Progression can be determined by RECIST 1.1, elevated tumor markers, worsening clinical symptoms or new lesions identified by FDG-PET or bone scan.
Time Frame From the time of start of study therapy to documented progression - up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vorinostat, AI Therapy)
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: months
2
(0 to 21)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is assessed relative to the start of the study therapy to the date of death, from any cause.
Time Frame From the time of start of study therapy to date of documented death
Hide Outcome Measure Data
Hide Analysis Population Description
OS includes one patient still alive 55 months after starting study therapy
Arm/Group Title Treatment (Vorinostat, AI Therapy)
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: months
19
(1 to 55)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Vorinostat, AI Therapy)
Hide Arm/Group Description

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
All-Cause Mortality
Treatment (Vorinostat, AI Therapy)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Treatment (Vorinostat, AI Therapy)
Affected / at Risk (%)
Total   2/15 (13.33%) 
Hepatobiliary disorders   
Liver failure [1]  1/15 (6.67%) 
Infections and infestations   
Fever [1]  1/15 (6.67%) 
[1]
Unrelated to the study treatment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Vorinostat, AI Therapy)
Affected / at Risk (%)
Total   8/15 (53.33%) 
Blood and lymphatic system disorders   
Thrombocytopenia [1]  2/15 (13.33%) 
neutropenia [2]  1/15 (6.67%) 
Gastrointestinal disorders   
vomiting [1]  2/15 (13.33%) 
diarrhea [2]  1/15 (6.67%) 
nausea [1]  2/15 (13.33%) 
General disorders   
Rigors / chills [1]  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
Muscle cramps [1]  1/15 (6.67%) 
Nervous system disorders   
Dizziness [3]  1/15 (6.67%) 
Renal and urinary disorders   
decrease in glomerular filtration [4]  1/15 (6.67%) 
creatinine increase [5]  2/15 (13.33%) 
[1]
grade 2 (CTCAE v3.0)
[2]
grade 3 (CTCAE v3.0)
[3]
grade 3 (CTCAE v3.0) The relationship to vorinostat was unclear.
[4]
grade 1 (CTCAE v3.0)
[5]
grade 1-2 (CTCAE v3.0)
[Not Specified]
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: Hannah Linden, MD
Organization: University of Washington
Phone: 206-288-6989
EMail: hmlinden@u.washington.edu
Layout table for additonal information
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01720602    
Other Study ID Numbers: 7841
NCI-2012-02004 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: October 31, 2012
First Posted: November 2, 2012
Results First Submitted: October 30, 2014
Results First Posted: November 6, 2014
Last Update Posted: January 7, 2020