Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT00365599
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • suberoylanilide hydroxamic acid (SAHA, Vorinostat) — DRUG
    Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days).
  • tamoxifen citrate (Tamoxifen) — DRUG
    Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).

Study Details

Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.

Key Dates

Start date
Feb 28, 2006
Status verified
Nov 2014
Primary completion
Apr 30, 2011
Completion
Aug 31, 2012

Study Design

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

Arms

  • Experimental: Vorinostat and Tamoxifen
    As outlined in Intervention descriptions

Primary Outcome Measure

Number of Participants With Objective Response (OR) [ Time Frame: 24 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94143-
Bethesda Memorial Hospital Research CenterBoynton BeachFlorida33435-
M.D. Anderson of OrlandoOrlandoFlorida32806-
Fawcett Memorial HospitalPort CharlotteFlorida33949-
Martin Memorial Cancer CenterStuartFlorida34994-
Tallahassee Memorial HealthCare, Inc.TallahasseeFlorida32308-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
St. Joseph's/CandlerSavannahGeorgia31405-

Find similar trials in San Francisco, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California· San Francisco, CABethesda Memorial Hospital Research Center· Boynton Beach, FLM.D. Anderson of Orlando· Orlando, FLFawcett Memorial Hospital· Port Charlotte, FLMartin Memorial Cancer Center· Stuart, FLTallahassee Memorial HealthCare, Inc.· Tallahassee, FL

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