Trial for Locally Advanced Her2 Positive Breast Cancer Using Paclitaxel, Trastuzumab, Doxorubicin and Cyclophasmide on a Weekly Basis
This trial is active, not recruiting.
|Treatments||vorinostat, paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, mastectomy or lumpectomy, post surgery therapy (trastuzumab)|
|Phase||phase 1/phase 2|
|Sponsor||Albert Einstein College of Medicine of Yeshiva University|
|Collaborator||Merck Sharp & Dohme Corp.|
|Start date||December 2007|
|End date||May 2014|
|Trial size||54 participants|
|Trial identifier||NCT00574587, 07-10-374, NCI-2013-01216, NYCC1|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To determine the recommended phase II dose of vorinostat in combination with weekly paclitaxel/trastuzumab
time frame: 1 year
To determine the pathological CR rate in patients with Her2/neu positive locally advanced breast cancer.
time frame: 2 years
Female participants at least 18 years old.
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
|Official title||Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel and Trastuzumab Followed by Doxorubicin-cyclophosphamide in Patients With Locally Advanced Breast Cancer|
|Principal investigator||Joseph Sparano, MD|
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