Study of Amrubicin With or Without Herceptin in Patients With Metastatic Breast Cancer
NCT ID: NCT00380835
Last Updated: 2008-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
66 participants
INTERVENTIONAL
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Amrubicin
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Principal Investigators
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Richard S Ungerleider, MD
Role: STUDY_DIRECTOR
Theradex
Locations
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New Milford, Connecticut, United States
Sharon, Connecticut, United States
Torrington, Connecticut, United States
Burnsville, Minnesota, United States
Edina, Minnesota, United States
Maplewood, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Woodbury, Minnesota, United States
Columbia, Missouri, United States
Albany, New York, United States
Amsterdam, New York, United States
Hudson, New York, United States
Latham, New York, United States
Rexford, New York, United States
Schenectady, New York, United States
Troy, New York, United States
Asheville, North Carolina, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Midland, Texas, United States
Odessa, Texas, United States
Plano, Texas, United States
Tyler, Texas, United States
Countries
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Other Identifiers
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CNF3140-MBC-001
Identifier Type: -
Identifier Source: org_study_id