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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00033768 | Other Identifier | Johns Hopkins |
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Difficulty meeting patient accrual goals
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.
Key eligibility criteria include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorinostat and Tamoxifen | Experimental | Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorinostat and Tamoxifen | Drug | vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Markers of Proliferation Prior to and After Study Drug Administration | To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery. | Baseline and 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vered Stearns, M.D. | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
Women 18 years or older with a histologically confirmed diagnosis of invasive mammary carcinoma on a core needle biopsy and with adequate organ function who are awaiting a definitive surgical procedure or initiation of neoadjuvant chemotherapy are eligible.
Patients will be recruited through the breast cancer clinics at each of the participating centers (ie, Johns Hopkins).
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat and Tamoxifen | Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat and Tamoxifen | Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Markers of Proliferation Prior to and After Study Drug Administration | To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery. | Two (2) participants were enrolled; however, due to difficulty in recruitment, we were not able to complete the study. There were not study-specific analyses completed or results to report. | Posted | Baseline and 14 days |
|
14 days
Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vorinostat and Tamoxifen | Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Unable to recruit participants to complete the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vered Stearns | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 4432876489 | vstearn1@jhmi.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| 0 |
| 2 |
| 2 |
| 2 |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |