Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT00574587
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose
  • Paclitaxel — DRUG
    Paclitaxel 80 mg/m2 weekly for 12 weeks
  • Trastuzumab — DRUG
    Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose
  • Doxorubicin — DRUG
    Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks
  • Cyclophosphamide — DRUG
    Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks
  • Surgery — PROCEDURE
    Surgical excision of tumor from breast

Study Details

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.

Key Dates

Start date
Dec 31, 2007
Status verified
Sep 2020
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

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

Arms

  • Experimental: Vorinostat Plus Paclitaxel
    Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks (and trastuzumab if HER2-positive), followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery

Primary Outcome Measure

Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab [ Time Frame: 3 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461-

Find similar trials in The Bronx, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Montefiore Medical Center· The Bronx, NY

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