Trial Outcomes & Findings for Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Aromatase Inhibitor Therapy (NCT NCT01153672)

Results Overview

Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Up to approximately 5 years

Results posted on

2019-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Aromatase Inhibitor Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) n=8 Participants Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 5 years

Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) n=8 Participants Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
Rate of Clinical Benefit According to RECIST	15 percentage of evaluable participants Interval 12.0 to 65.0

PRIMARY outcome

Timeframe: Up to approximately 5 years

Duration of response will be summarized for responders.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) n=2 Participants Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
Duration of Response	25.4 weeks Interval 18.3 to 32.4

SECONDARY outcome

Timeframe: Time elapsed from the first day of study treatment, until disease progression or death, assessed up to approximately 5 years

Kaplan-Meier survival curves will be used to describe progression-free survival. For progression-free survival, patients without documented disease progression or death will be treated as censored observations on the date of the last tumor assessment.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) n=8 Participants Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
Progression-free Survival	2.8 months Interval 1.9 to 13.3

SECONDARY outcome

Timeframe: Time elapsed from the first day of study treatment until death, assessed up to approximately 5 years

Kaplan-Meier survival curves will be used to describe overall survival. Overall survival time will be censored on the last date the patient was known to be alive.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) n=8 Participants Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
Overall Survival	28.8 months Interval 16.2 to 54.5

SECONDARY outcome

Timeframe: Up to approximately 5 years

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) n=8 Participants Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	37.5 percentage of participants

Adverse Events

Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) n=8 participants at risk Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
Infections and infestations Flu-like symptoms	12.5% 1/8
Gastrointestinal disorders pancreatitis	12.5% 1/8

Other adverse events

Other adverse events
Measure	Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) n=8 participants at risk Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO laboratory biomarker analysis: Correlative studies biopsy: Optional correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies positron emission tomography: Correlative studies anastrozole: Given PO letrozole: Given PO exemestane: Given PO gene expression analysis: Correlative studies
General disorders Fatigue	25.0% 2/8

Additional Information

Hannah M. 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