Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer
NCT ID: NCT00955890
Last Updated: 2012-02-28
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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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2009-06-30
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control arm
anthracycline chemotherapy only
No interventions assigned to this group
low dose dexrazoxane group
anthracycline chemotherapy plus low dose dexrazoxane(10:1)
Dexrazoxane hydrochloride
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
middle dose dexrazoxane group
anthracycline chemotherapy plus middle dose dexrazoxane(15:1)
Dexrazoxane hydrochloride
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
Dexrazoxane hydrochloride
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
Interventions
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Dexrazoxane hydrochloride
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
Dexrazoxane hydrochloride
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed primary infiltrating adenocarcinoma of the breast
* Confirmed by core needle biopsy or incisional biopsy or surgery
* Experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy
* At least 2 cycles same anthracycline based chemotherapy are needed
Exclusion Criteria
* With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); Prior or Concurrent radiation to heart
* Pregnant or nursing
* Other currently active malignancy except nonmelanoma skin cancer
* Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
* Grade 2 or more Cardiac Toxicity (CTC AE3.0)
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xichun Hu
Dr
Principal Investigators
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xichun Hu, MD
Role: PRINCIPAL_INVESTIGATOR
member of Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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MBC0901 FUCH
Identifier Type: -
Identifier Source: org_study_id
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