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Completed

NCT Number: NCT00574587

Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10461, United States

About this study

This is a phase I-II trial in which patients with stage IIB-IIIC breast cancer will receive:

  • Neoadjuvant weekly paclitaxel (80 mg/m2 IV weekly x 12 weeks) plus vorinostat (200 or 300 mg PO BID on days 1-3 each paclitaxel dose) and trastuzumab (4 mg/kg loading dose, 2 mg/kg IV weekly x 12 total doses if HER2 positive, followed by:
  • Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 2 weeks x 4 cycles (plus G-CSF), followed by:
  • Surgery (lumpectomy or mastectomy)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed adenocarcinoma of the breast associated with the following stages: IIB, IIIA, IIIB or IIIC.
  • Tumor must be Her2/neu positive
  • No prior chemotherapy, radiation or definitive therapeutic surgery

Exclusion criteria

  • May not be receiving any other investigational agents
  • Uncontrolled intercurrent illness

Treatment and study plan

Vorinostat

Drug

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

Other names: Zolinza

paclitaxel

Drug

Paclitaxel 80 mg/m2 weekly for 12 weeks

Other names: Taxol

Trastuzumab

Drug

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

Other names: Perception

Doxorubicin

Drug

Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks

Other names: Adriamycin

Cyclophosphamide

Drug

Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks

Other names: Cytoxan

Surgery

Procedure

Surgical excision of tumor from breast

Other names: Mastectomy or lumpectomy

Primary outcomes

  1. Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab

    Time frame: 3 weeks

    Dose limiting toxicity in cycle 1

Secondary outcomes

  1. Pathological Complete Response (CR) Rate in Patients With Her2/Neu Positive Locally Advanced Breast Cancer.

    Time frame: 6 months

    Pathological Complete Response (CR) defined as absence of invasive cancer at surgery

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel (+/- Trastuzumab) Followed by Doxorubicin-cyclophosphamide in Patients With Locally Advanced Breast Cancer

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2007
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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