A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

Phase 2

Terminated

• Conditions: Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Invasive Breast Cancer
• Interventions: Drug: Vorinostat and Tamoxifen

• Registration Number: NCT01194427
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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 Timeline

• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-03
• Study Start: 2011-03
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-03-18
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-15
• Last Update Submitted: 2013-05-15
• Results First Posted: 2013-05-17
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vorinostat and Tamoxifen	Vorinostat and Tamoxifen	Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.

Primary Outcome Measures

Name	Time	Method
Changes in Markers of Proliferation Prior to and After Study Drug Administration	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.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States