Phase 2
Completed N=55
Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy
Source: ClinicalTrials.gov NCT00574587 ↗Enrolled (actual)
55
Serious AEs
5.5%
Results posted
Sep 2020
Primary outcomePrimary: Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab — 300; 300 mg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab |
300; 300 | — |
| SECONDARY Pathological Complete Response (CR) Rate in Patients With Her2/Neu Positive Locally Advanced Breast Cancer. |
13; 4; 0 | <0.10 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00574587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.