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Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy

NCT00574587 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-10-14

Study results available
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Summary

Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other genes in the cancer cells that are repressed; when the genes are turned back on by the drug, it leads to death of the cancer cells. HDAC inhibitors such as vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in experimental systems. The purpose of this trial is to determine the optimal dose of vorinostat to use in combination with standard chemotherapy alone (or in combination with plus trastuzumab for HER2-positive disease), and to determine whether vorinostat enhances the effectiveness of standard chemotherapy (+/- trastuzumab) in patients with locally advanced breast cancer.

Conditions

Interventions

DRUG

Vorinostat

Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 weekly for 12 weeks

DRUG

Trastuzumab

Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose

DRUG

Doxorubicin

Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks

DRUG

Cyclophosphamide

Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks

PROCEDURE

Surgery

Surgical excision of tumor from breast

Sponsors & Collaborators

Principal Investigators

  • Joseph Sparano, MD · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00574587 on ClinicalTrials.gov