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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dexrazoxane hydrochloride
Dexrazoxane hydrochloride
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring cardioprotection, anthracycline chemotherapy, breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control arm

low dose dexrazoxane group

middle dose dexrazoxane group

Arm Description

anthracycline chemotherapy only

anthracycline chemotherapy plus low dose dexrazoxane(10:1)

anthracycline chemotherapy plus middle dose dexrazoxane(15:1)

Outcomes

Primary Outcome Measures

Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy

Secondary Outcome Measures

Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity

Full Information

First Posted
August 7, 2009
Last Updated
February 27, 2012
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT00955890
Brief Title
Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer
Acronym
cardioprotec
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Enrolled too slow
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
cardioprotection, anthracycline chemotherapy, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control arm
Arm Type
No Intervention
Arm Description
anthracycline chemotherapy only
Arm Title
low dose dexrazoxane group
Arm Type
Experimental
Arm Description
anthracycline chemotherapy plus low dose dexrazoxane(10:1)
Arm Title
middle dose dexrazoxane group
Arm Type
Experimental
Arm Description
anthracycline chemotherapy plus middle dose dexrazoxane(15:1)
Intervention Type
Drug
Intervention Name(s)
Dexrazoxane hydrochloride
Other Intervention Name(s)
Dexrazoxane for Injection
Intervention Description
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Dexrazoxane hydrochloride
Other Intervention Name(s)
dexrazoxane injection
Intervention Description
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
Primary Outcome Measure Information:
Title
Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xichun Hu, MD
Organizational Affiliation
member of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

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