A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

This study has been terminated.
(Difficulty meeting patient accrual goals)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01194427
First received: March 25, 2010
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Invasive Breast Cancer
Drug: Vorinostat and Tamoxifen
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Changes in Markers of Proliferation Prior to and After Study Drug Administration [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vorinostat and Tamoxifen
Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Drug: Vorinostat and Tamoxifen
vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days
Other Name: Zolinza

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194427

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Vered Stearns, M.D. Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01194427     History of Changes
Other Study ID Numbers: J09144, NA_00033768
Study First Received: March 25, 2010
Results First Received: March 18, 2013
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Preoperative
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Vorinostat
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014