Trial for Locally Advanced Her2 Positive Breast Cancer Using Paclitaxel, Trastuzumab, Doxorubicin and Cyclophasmide on a Weekly Basis
Information source: Montefiore Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Vorinostat (Drug); Paclitaxel (Drug); Trastuzumab (Drug); Doxorubicin (Drug); Cyclophosphamide (Drug); Mastectomy or Lumpectomy (Procedure); Post surgery therapy (Trastuzumab) (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s):
Joseph Sparano, MD, Principal Investigator, Affiliation: Montefiore Medical Center
Overall contact:
Lisa M Escobar-Peralta, BS, Phone: 718-904-2730, Email: lescobar@montefiore.org
Summary
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.
Clinical Details
Official title: Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel and Trastuzumab Followed by Doxorubicin-Cyclophosphamide in Patients With Locally Advanced Breast Cancer
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To determine the recommended phase II dose of vorinostat in combination with weekly paclitaxel/trastuzumab
Secondary outcome: To determine the pathological CR rate in patients with Her2/neu positive locally advanced breast cancer.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Lisa M Escobar-Peralta, BS, Phone: 718-904-2730, Email: lescobar@montefiore.org
Montefiore Medical Center, Bronx, New York 10461, United States; Recruiting
Lisa M Escobar, BS, Phone: 718-904-2730, Email: lescobar@montefiore.org
Joseph Sparano, MD, Principal Investigator
Additional Information
Starting date: December 2007
Ending date: January 2010
Last updated: December 14, 2007
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