Status:
TERMINATED
A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Stage I Breast Cancer
Stage II Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 th...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01194427
Start Date
March 1 2011
End Date
November 1 2011
Last Update
May 17 2013
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287