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

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ClinicalTrials.gov Identifier: NCT01720602
Recruitment Status : Active, not recruiting
First Posted : November 2, 2012
Results First Posted : November 6, 2014
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Study Type Interventional
Study Design 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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 Kaplan-Meier survival curves will be used to describe PFS.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival
Hide Description Kaplan-Meier survival curves will be used to describe overall survival.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
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   --/-- 
Show Serious Adverse Events 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
Show Other (Not Including Serious) Adverse Events 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)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Hannah Linden, MD
Organization: University of Washington
Phone: 206-288-6989
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01720602     History of Changes
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: May 15, 2018