Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2014-05-31

Brief Summary

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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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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

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

Paclitaxel

Intervention Type DRUG

Paclitaxel 80 mg/m2 weekly for 12 weeks

Trastuzumab

Intervention Type DRUG

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

Doxorubicin

Intervention Type DRUG

Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks

Surgery

Intervention Type PROCEDURE

Surgical excision of tumor from breast

Interventions

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Vorinostat

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

Intervention Type DRUG

Paclitaxel

Paclitaxel 80 mg/m2 weekly for 12 weeks

Intervention Type DRUG

Trastuzumab

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

Intervention Type DRUG

Doxorubicin

Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks

Intervention Type DRUG

Cyclophosphamide

Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks

Intervention Type DRUG

Surgery

Surgical excision of tumor from breast

Intervention Type PROCEDURE

Other Intervention Names

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Zolinza Taxol Perception Adriamycin Cytoxan Mastectomy or lumpectomy

Eligibility Criteria

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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