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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01194427
Other study ID # J09144
Secondary ID NA_00033768
Status Terminated
Phase Phase 2
First received March 25, 2010
Last updated May 15, 2013
Start date March 2011
Est. completion date November 2011

Study information

Verified date May 2013
Source Sidney Kimmel Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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 this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
Vorinostat and Tamoxifen
vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days

Locations

Country Name City State
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Baseline and 14 days No
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