- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01194427
A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer
May 15, 2013 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Key eligibility criteria include:
- Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
- No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
- No prior or current use of any therapy to treat the current breast cancer.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21287
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Stage I-III invasive breast cancer
- Awaiting surgery or neoadjuvant treatment
- ECOG performance status 0, 1 or 2
- Adequate organ function
- Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)
Exclusion Criteria:
- Prior or current treatment of any kind for the current breast cancer
- Current use of any other investigational drugs
- Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vorinostat and Tamoxifen
Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
|
vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Markers of Proliferation Prior to and After Study Drug Administration
Time Frame: Baseline and 14 days
|
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.
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Baseline and 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Vered Stearns, M.D., Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
March 25, 2010
First Submitted That Met QC Criteria
September 1, 2010
First Posted (Estimate)
September 3, 2010
Study Record Updates
Last Update Posted (Estimate)
May 17, 2013
Last Update Submitted That Met QC Criteria
May 15, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Histone Deacetylase Inhibitors
- Tamoxifen
- Vorinostat
Other Study ID Numbers
- J09144
- NA_00033768 (Other Identifier: Johns Hopkins)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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