A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Invasive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vorinostat and Tamoxifen

Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.

Group Type EXPERIMENTAL

Vorinostat and Tamoxifen

Intervention Type DRUG

vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days

Interventions

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Vorinostat and Tamoxifen

vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days

Intervention Type DRUG

Other Intervention Names

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Zolinza

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No