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

NCT00365599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-11-21

Study results available
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Summary

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

Conditions

Interventions

DRUG

suberoylanilide hydroxamic acid (SAHA, Vorinostat)

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).

DRUG

tamoxifen citrate (Tamoxifen)

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).

Sponsors & Collaborators

Principal Investigators

  • Susan Minton, D.O. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2011-04-30
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00365599 on ClinicalTrials.gov