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

February 27, 2012 updated by: Xichun Hu, Fudan University

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Dexrazoxane for Injection
Drug: Dexrazoxane hydrochloride
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
Other Names:
  • dexrazoxane 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 Names:
  • Dexrazoxane for Injection
Drug: Dexrazoxane hydrochloride
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
Other Names:
  • dexrazoxane injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: xichun Hu, MD, member of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBC0901 FUCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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