Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
NCT ID: NCT00608972
Last Updated: 2023-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2008-05-16
2015-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Doxil, Carboplatin and Bevacizumab
Doxil
Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Carboplatin
Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Bevacizumab
Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Interventions
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Doxil
Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Carboplatin
Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Bevacizumab
Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>= 18
3. ECOG performance status \<= 2
4. Normal organ and marrow function
5. Normal cardiac function as evidenced by LVEF within institutional normal limits
Exclusion Criteria
2. Myocardial infarct or unstable angina within 6 months before enrollment
3. Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720 mg/m2 for epirubicin.
4. Proteinuria
18 Years
FEMALE
No
Sponsors
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Rutgers Cancer Institute of New Jersey
OTHER
National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Deborah Toppmeyer, MD
Professor, CINJ
Principal Investigators
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Deborah Toppmeyer, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Cooper Hospital/University Medical Center
Camden, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
Countries
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Provided Documents
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Document Type: Study Protocol: Protocol #1
Document Type: Study Protocol: Protocol #2
Document Type: Study Protocol and Statistical Analysis Plan: Protocol #4SAP
Document Type: Informed Consent Form
Related Links
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ICH GCP Clinical Trials Registry
Other Identifiers
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NJ 2107
Identifier Type: -
Identifier Source: secondary_id
Pro0220070274
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-00524
Identifier Type: OTHER
Identifier Source: secondary_id
040702
Identifier Type: -
Identifier Source: org_study_id
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