Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer (cardioprotec)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00955890
Recruitment Status : Terminated (Enrolled too slow)
First Posted : August 10, 2009
Last Update Posted : February 28, 2012
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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 of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent correlations between the total cumulative dose of doxorubicin, the severity of the resulting cardiomyopathy, and the level of serum troponin-T.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Dexrazoxane hydrochloride Phase 2

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 patient receive at least 2 cycles anthracycline chemotherapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: control arm
anthracycline chemotherapy only
Experimental: low dose dexrazoxane group
anthracycline chemotherapy plus low dose dexrazoxane(10:1)
Drug: Dexrazoxane hydrochloride
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
Other Name: Dexrazoxane for Injection
Experimental: middle dose dexrazoxane group
anthracycline chemotherapy plus middle dose dexrazoxane(15:1)
Drug: Dexrazoxane hydrochloride
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
Other Name: Dexrazoxane for Injection
Drug: Dexrazoxane hydrochloride
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
Other Name: dexrazoxane injection

Primary Outcome Measures :
  1. Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00955890

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: xichun Hu, MD member of Fudan University

Responsible Party: Xichun Hu, Dr, Fudan University Identifier: NCT00955890     History of Changes
Other Study ID Numbers: MBC0901 FUCH
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by Xichun Hu, Fudan University:
anthracycline chemotherapy
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Cardiotonic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimitotic Agents
Mitosis Modulators