Trial Outcomes & Findings for Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy (NCT NCT01720602)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Vorinostat, AI Therapy) 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 Study STARTED	15
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Vorinostat, AI Therapy) 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 Study Adverse Event	3
Overall Study Progressive disease on therapy	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Vorinostat, AI Therapy) n=15 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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).

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat, AI Therapy) n=10 Participants 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
Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST	60 percentage of patients Interval 35.0 to 81.0

PRIMARY outcome

Timeframe: 8 weeks

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).

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat, AI Therapy) n=10 Participants 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
Response Rate According to RECIST	60 percentage of patients Interval 35.0 to 81.0

SECONDARY outcome

Timeframe: Up to 5 years

Duration of response will be summarized for responders.

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat, AI Therapy) n=6 Participants 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
Duration of Response	29.6 weeks Interval 24.9 to 91.4

SECONDARY outcome

Timeframe: From the time of start of study therapy to documented progression - up to 5 years

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.

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat, AI Therapy) n=15 Participants 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
Progression-free Survival (PFS)	2 months Interval 0.0 to 21.0

SECONDARY outcome

Timeframe: From the time of start of study therapy to date of documented death

Population: OS includes one patient still alive 55 months after starting study therapy

Overall survival is assessed relative to the start of the study therapy to the date of death, from any cause.

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat, AI Therapy) n=15 Participants 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 Survival	19 months Interval 1.0 to 55.0

Adverse Events

Treatment (Vorinostat, AI Therapy)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Vorinostat, AI Therapy) n=15 participants at risk 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
Hepatobiliary disorders Liver failure	6.7% 1/15
Infections and infestations Fever	6.7% 1/15

Other adverse events

Other adverse events
Measure	Treatment (Vorinostat, AI Therapy) n=15 participants at risk 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
Renal and urinary disorders decrease in glomerular filtration	6.7% 1/15
Renal and urinary disorders creatinine increase	13.3% 2/15
Blood and lymphatic system disorders Thrombocytopenia	13.3% 2/15
Gastrointestinal disorders vomiting	13.3% 2/15
Gastrointestinal disorders diarrhea	6.7% 1/15
Gastrointestinal disorders nausea	13.3% 2/15
Blood and lymphatic system disorders neutropenia	6.7% 1/15
Musculoskeletal and connective tissue disorders Muscle cramps	6.7% 1/15
General disorders Rigors / chills	6.7% 1/15
Nervous system disorders Dizziness	6.7% 1/15

Additional Information

Hannah Linden, MD

University of Washington

Phone: 206-288-6989

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place