Trial for Locally Advanced Her2 Positive Breast Cancer Using Paclitaxel, Trastuzumab, Doxorubicin and Cyclophasmide on a Weekly Basis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2007 |
| End Date: | January 2016 |
Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel and Trastuzumab Followed by Doxorubicin-cyclophosphamide in Patients With Locally Advanced Breast Cancer
Chemotherapy plus trastuzumab (Herceptin) are standard treatments for breast cancer. There
are circumstances where these treatments are given prior to surgery to reduce the size of
the cancer and imptove the surgical outcome. In this trial, an oral drug called "vorinostat"
will be given in combination with chemotherapy and trastuzumab. 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 plus trastuzumab, and to determine whether vorinostat enhances the
effectiveness of standard chemotherapy plus trastuzumab.
are circumstances where these treatments are given prior to surgery to reduce the size of
the cancer and imptove the surgical outcome. In this trial, an oral drug called "vorinostat"
will be given in combination with chemotherapy and trastuzumab. 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 plus trastuzumab, and to determine whether vorinostat enhances the
effectiveness of standard chemotherapy plus trastuzumab.
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
We found this trial at
1
site
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
