Status:
TERMINATED
Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects ...
Detailed Description
Patients with breast cancer receiving anthracycline chemotherapy randomized to 3 groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane, chemotherapy only.Every patien...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
- Accumulated dose of EPI ≥1000mg/m2,ADM≥550mg/m2
- 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)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00955890
Start Date
June 1 2009
End Date
February 1 2012
Last Update
February 28 2012
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032