Study Stopped
Study Never Initiated
Study of Amrubicin With or Without Herceptin in Patients With Metastatic Breast Cancer
A Phase 2 Trial of Amrubicin With or Without Herceptin in the Treatment of Metastatic Breast Cancer
1 other identifier
interventional
66
1 country
28
Brief Summary
The purpose of the study is to evaluate the incidence of cardiac toxicity of amrubicin when administered to patients with metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
28 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
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedSeptember 23, 2008
September 1, 2008
September 26, 2006
September 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of cardiac toxicity
Secondary Outcomes (5)
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Duration of overall response
Time to tumor progression
Progression free survival
Toxicity profile
Interventions
Eligibility Criteria
You may qualify if:
- Histological or cytological diagnosis of breast cancer.
- Metastatic or recurrent disease, either HER2+ (FISH+ or 3+ IHC) or HER2-.
- Maximal dose of prior adjuvant anthracycline: 300 mg/meters squared doxorubicin or equivalent. Relapse greater than one year after trastuzumab adjuvantly; two years following adjuvant anthracycline therapy (without trastuzumab).
- One prior chemotherapy for metastatic breast cancer allowed (may include trastuzumab for HER2+ patients), but no prior Doxil, adriamycin or epirubicin for metastatic breast cancer.
- At least 18 years of age.
- ECOG Performance Status of 0, 1, or 2.
- Adequate organ function including the following:
- Adequate bone marrow reserve.
- Cardiac: Left ventricular ejection fraction (LVEF) greater than or equal to 55% by MUGA.
- Negative serum pregnancy test at the time of enrollment for women of child-bearing potential.
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.
You may not qualify if:
- Pregnant or nursing women.
- Concurrent anticancer therapy.
- Participation in any investigational drug study within 28 days prior to study entry.
- Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, uncontrolled hypertension, coronary artery disease, congestive heart failure, severe arrhythmia) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
- Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for greater than or equal to 2 weeks and off corticosteroids for greater than or equal to 1 week.
- History of interstitial lung disease or pulmonary fibrosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
New Milford, Connecticut, 06776, United States
Unknown Facility
Sharon, Connecticut, 06069, United States
Unknown Facility
Torrington, Connecticut, 06790, United States
Unknown Facility
Burnsville, Minnesota, 55337, United States
Unknown Facility
Edina, Minnesota, 55435-2150, United States
Unknown Facility
Maplewood, Minnesota, 55109, United States
Unknown Facility
Minneapolis, Minnesota, 55404, United States
Unknown Facility
Saint Paul, Minnesota, 55102-2389, United States
Unknown Facility
Woodbury, Minnesota, 55125, United States
Unknown Facility
Columbia, Missouri, 65201, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Amsterdam, New York, 12010, United States
Unknown Facility
Hudson, New York, 12534, United States
Unknown Facility
Latham, New York, 12110-0610, United States
Unknown Facility
Rexford, New York, 12148, United States
Unknown Facility
Schenectady, New York, 12308, United States
Unknown Facility
Troy, New York, 12180, United States
Unknown Facility
Asheville, North Carolina, 28803, United States
Unknown Facility
Dallas, Texas, 75230-2510, United States
Unknown Facility
Dallas, Texas, 75231-4400, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
El Paso, Texas, 79902, United States
Unknown Facility
El Paso, Texas, 79915, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
Midland, Texas, 79701-5946, United States
Unknown Facility
Odessa, Texas, 79761, United States
Unknown Facility
Plano, Texas, 75075-7787, United States
Unknown Facility
Tyler, Texas, 75702, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard S Ungerleider, MD
Theradex
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 27, 2006
Study Completion
December 1, 2007
Last Updated
September 23, 2008
Record last verified: 2008-09