Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2012

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.

Interventions

  • Drug: Dexrazoxane hydrochloride
    • pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
  • Drug: Dexrazoxane hydrochloride
    • pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks

Arms, Groups and Cohorts

  • No Intervention: control arm
    • anthracycline chemotherapy only
  • Experimental: low dose dexrazoxane group
    • anthracycline chemotherapy plus low dose dexrazoxane(10:1)
  • Experimental: middle dose dexrazoxane group
    • anthracycline chemotherapy plus middle dose dexrazoxane(15:1)

Clinical Trial Outcome Measures

Primary Measures

  • Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy
    • Time Frame: 1 year

Secondary Measures

  • Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity
    • Time Frame: 1 year

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xichun Hu, Dr – Fudan University
  • Overall Official(s)
    • xichun Hu, MD, Principal Investigator, member of Fudan University

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