Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT01720602
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
  • anastrozole — DRUG
    Given PO
  • letrozole — DRUG
    Given PO
  • exemestane — DRUG
    Given PO
  • positron emission tomography — PROCEDURE
    Correlative studies
  • F-18 16 alpha-fluoroestradiol — RADIATION
    Correlative studies
  • fludeoxyglucose F 18 — RADIATION
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer receiving hormone therapy. Vorinostat may help hormone therapy work better by making tumor cells more sensitive to the drug.

Key Dates

Start date
Nov 30, 2012
Status verified
Jan 2020
Primary completion
Mar 31, 2015
Completion
Jan 31, 2020

Study Design

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

Arms

  • Experimental: Treatment (vorinostat, AI therapy)
    Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.

Primary Outcome Measure

Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST [ Time Frame: 8 weeks ]

Locations (1)

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

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

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