A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

Stage II Breast Cancer Clinical Trial

Official title:

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

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer

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