NCT00574587

Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase I-II trial in which patients with stage IIB-IIIC breast cancer will receive: 1. 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: 2. Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 2 weeks x 4 cycles (plus G-CSF), followed by: 3. Surgery (lumpectomy or mastectomy)

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2007-12-17
• Last updated: 2020-10-14
• Results posted: 2020-09-18

Locations

1 site across 1 country: United States