An interventional study of vorinostat and laboratory biomarker analysis in Male Breast Cancer, Recurrent Breast Cancer and Stage IV Breast Cancer, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer receiving aromatase inhibitor (AI) therapy. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help AI therapy work better by making tumor cells more sensitive to the drug
PRIMARY OBJECTIVES:
I. Determine the rate of clinical benefit (objective response plus stable disease) for patients treated with cycles consisting of 2 weeks of vorinostat followed by 6 weeks of AI therapy.
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of vorinostat in patients with metastatic breast cancer.
II. Assess the change in estrogen receptor (ER) expression, measured as the change in fluoroestradiol standard uptake value (FES SUV) using fluoroestradiol-positron emission tomography (FES-PET) completed per protocol 7184 after two weeks of vorinostat therapy and after 8 weeks of therapy.
III. Assess tumor metabolic response, measured as the change in fluorodeoxyglucose (FDG) SUV using FDG PET completed per protocol 7184 after two weeks of vorinostat therapy and after 8 weeks of therapy.
IV. Assess the change in hormone levels (estradiol, estrone, follicle-stimulating hormone [FSH], sex binding globulin, testosterone, and free testosterone) after 8 weeks of therapy.
V. Assess the change in ER, progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), androgen receptor (AR), epithelial growth factor receptor (EGFR), vascular endothelial growth factor (VEGF) tumor expression after two weeks of vorinostat therapy in patients that consent to optional tissue biopsy procedure.
VI. Assess the time to progression and the overall survival of patients treated with cycles of 2 weeks of vorinostat followed by 6 weeks of AI.
OUTLINE:
Patients receive vorinostat orally (PO) once daily (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.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months until disease progression, and then annually thereafter.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 8 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: vorinostat · Other: laboratory biomarker analysis · Procedure: biopsy · Radiation: F-18 16 alpha-fluoroestradiol · Procedure: positron emission tomography · Drug: anastrozole · Drug: letrozole · Drug: exemestane · Genetic: gene expression analysis
Given PO
Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Correlative studies
Optional correlative studies
Also known as: biopsies
Correlative studies
Also known as: F-18 FES, fluorine-18 16 alpha-fluoroestradiol
Correlative studies
Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Given PO
Also known as: ANAS, Arimidex, ICI-D1033
Given PO
Also known as: CGS 20267, Femara, LTZ
Given PO
Also known as: Aromasin, FCE-24304, PNU 155971
Correlative studies
Rate of Clinical Benefit According to RECIST
Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria
Time frame: Up to approximately 5 years
Duration of Response
Duration of response will be summarized for responders.
Time frame: Up to approximately 5 years
Progression-free Survival
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.
Time frame: Time elapsed from the first day of study treatment, until disease progression or death, assessed up to approximately 5 years
Overall Survival
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.
Time frame: Time elapsed from the first day of study treatment until death, assessed up to approximately 5 years
Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: Up to approximately 5 years
| Milestone | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| Started | 8 |
| Completed | 6 |
| Not completed | 2 |
Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria
| percentage of evaluable participants | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| Rate of Clinical Benefit According to RECIST | 15 (12 to 65) |
Duration of response will be summarized for responders.
| weeks | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| Duration of Response | 25.4 (18.3 to 32.4) |
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.
| months | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| Progression-free Survival | 2.8 (1.9 to 13.3) |
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.
| months | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| Overall Survival | 28.8 (16.2 to 54.5) |
| percentage of participants | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | 37.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) | — | 2/8 (25%) | 2/8 (25%) |
| Event | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| Flu-like symptomsInfections and infestations | 1/8 |
| pancreatitisGastrointestinal disorders | 1/8 |
| Event | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| FatigueGeneral disorders | 2/8 |
| Age, Categorical(Participants) | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy) |
|---|---|
| Female | 8 |
| Male | 0 |
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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