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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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2006-10-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Pegylated Liposomal Doxorubicin (Doxil)
Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Interval between diagnosis and consent of \<- 62 days
* Life expectancy of 10 years
* LVEF by MUGA \>= lower limit of normal for the testing facility
* Negative serum pregnancy test
* Adequate bone marrow, renal, liver function
* Negative bone scan
* HRT discontinued before study entry
* Adequate contraceptive methods
Exclusion Criteria
* Less than 21 years of age
* Ulceration, infiltration of the skin, complete fixation or severe skin edema
* N3 disease in which nodes are matted and fixed
* Suspicious palpable supraclavicular nodes
* CT evidence of malignant internal mammary nodes
* Pregnancy or breast feeding at time of study entry
* Prior therapy for breast cancer
* Prior anthracycline for any malignancy
* Prior breast malignancy of the contralateral breast
* Prior non-breast malignancy within 5 years
* Non-malignant disease that would preclude follow up
* MI within 6 months, NYHA Class II or greater heart failure
* Psychiatric disorders or conditions that would preclude provision of informed consent
21 Years
FEMALE
No
Sponsors
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Ortho Biotech Products, L.P.
INDUSTRY
Aptium Oncology Research Network
NETWORK
Responsible Party
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Aptium Oncology Research Network
Principal Investigators
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John Macdonald, MD
Role: STUDY_DIRECTOR
CMO Aptium Oncology
Locations
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Providence St. Joseph Medical Hospital
Burbank, California, United States
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States
Lynn Regional Cancer Center West
Boca Raton, Florida, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
St Vincent Comprehensive Cancer Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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06BR01
Identifier Type: -
Identifier Source: org_study_id
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