Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer
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
4 other identifiers
interventional
16
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Aug 2006
Typical duration for phase_1 breast-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2005
CompletedFirst Posted
Study publicly available on registry
November 24, 2005
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
September 27, 2012
CompletedJune 2, 2014
October 1, 2013
4 years
November 22, 2005
August 28, 2012
May 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Response Rate
Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy
Secondary Outcomes (2)
Time to Progression
Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy
Overall Survival
Survival was assessed every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry
Study Arms (1)
Arm I
EXPERIMENTALPatients will receive vorinostat by mouth twice a day for 2 weeks. They will also receive a 90-minute infusion of trastuzumab in week 1.
Interventions
Eligibility Criteria
You may qualify if:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active or ongoing infection
- No history of allergic reaction to compounds of similar chemical or biologic composition to vorinostat or other agents used in study
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin; 1 week for capecitabine) and recovered
- More than 3 weeks since prior radiotherapy and recovered
- Recovered from prior therapy
- At least 2 weeks since prior valproic acid
- More than 4 weeks since prior investigational agents
- More than 4 weeks since prior lapatinib ditosylate
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Measurable disease, defined as \>= 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mercy Capitol
Des Moines, Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa Oncology Research Association CCOP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8936, United States
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Woodwinds Health Campus
Woodbury, Minnesota, 55125, United States
Saint Vincent's Hospital and Medical Center of New York
New York, New York, 10011, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- Eastern Cooperative Oncology Group (ECOG) Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Ramona Swaby
Eastern Cooperative Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2005
First Posted
November 24, 2005
Study Start
August 1, 2006
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
June 2, 2014
Results First Posted
September 27, 2012
Record last verified: 2013-10