CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
vorinostat +1 moredrug
Likely dose
Vorinostat (SAHA) orally plus trastuzumab intravenously (specific doses not stated in criteria)AI-extracted
Key inclusion· 6
  • Histologically confirmed breast cancer with HER-2 overexpression
  • Metastatic or chest wall recurrent disease
  • Recurrent or progressive disease on prior trastuzumab, or relapsed within 3 months of adjuvant trastuzumab
  • Measurable disease ≥20 mm by conventional imaging or ≥10 mm by spiral CT
Key exclusion· 6
  • No untreated brain metastases; treated metastases allowed if not the sole measurable disease site
  • No active or ongoing infection
  • No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00258349
NCT00258349Phase 2Completed

A Phase I/II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Trastuzumab (Herceptin) in Patients With Advanced Metastatic and/or Local Chest Wall Recurrent Her-2 Amplified Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Nov 24, 2005·Updated Jun 2, 2014

In Brief

A Phase 2 clinical trial evaluating vorinostat and trastuzumab for Breast Cancer and 5 related conditions. Completed, enrolled 16 participants across 25 sites.

Detailed Summary

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Vorinostat and trastuzumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with trastuzumab may be a better way to block tumor growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 24, 2005
Enrollment StartAug 1, 2006
Primary CompletionAug 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.6 years ago

Interventions

vorinostatdrug

Given orally

trastuzumabdrug

Given IV