Randomized Phase II Trial Of Interventional Therapy Investigate Cardiac Protection of Dexrazoxane In Women With Breast Cancer Having Experienced Grade 1 Cardiotoxicity During Prior Anthracycline-based Chemotherapy.
18 Years
70 Years
Female
Breast Cancer
Trial Information
Randomized Phase II Trial Of Interventional Therapy Investigate Cardiac Protection of Dexrazoxane In Women With Breast Cancer Having Experienced Grade 1 Cardiotoxicity During Prior Anthracycline-based Chemotherapy.
Patients with breast cancer receiving anthracycline chemotherapy randomized to 3
groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane,
chemotherapy only.Every patient receive at least 2 cycles anthracycline chemotherapy.
Inclusion Criteria:
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 Criteria:
- 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
xichun Hu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
member of Fudan University
Authority:
China: Food and Drug Administration
Study ID:
MBC0901 FUCH
NCT ID:
NCT00955890
Start Date:
June 2009
Completion Date:
February 2012
Related Keywords:
- Breast Cancer
- cardioprotection
- anthracycline chemotherapy
- breast cancer
- Breast Neoplasms
Name | Location |
|---|
