Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Aromatase Inhibitor Therapy

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT01153672
Status
Completed

Conditions

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • biopsy — PROCEDURE
    Optional correlative studies
  • F-18 16 alpha-fluoroestradiol — RADIATION
    Correlative studies
  • positron emission tomography — PROCEDURE
    Correlative studies
  • anastrozole — DRUG
    Given PO
  • letrozole — DRUG
    Given PO
  • exemestane — DRUG
    Given PO
  • gene expression analysis — GENETIC
    Correlative studies

Study Details

This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer receiving aromatase inhibitor (AI) therapy. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help AI therapy work better by making tumor cells more sensitive to the drug

Key Dates

Start date
Nov 30, 2010
Status verified
Aug 2019
Primary completion
Jul 31, 2012
Completion
Aug 11, 2016

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (enzyme inhibitor therapy, AI sensitization therapy)
    Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Rate of Clinical Benefit According to RECIST [ Time Frame: Up to approximately 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-

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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium· Seattle, WA

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