Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Dexrazoxane hydrochloride
* Drug: Dexrazoxane hydrochloride


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control arm<br>anthracycline chemotherapy only | |
| Experimental: low dose dexrazoxane group<br>anthracycline chemotherapy plus low dose dexrazoxane(10:1) | Drug: Dexrazoxane hydrochloride<br>* pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks<br>* Other names: Dexrazoxane for Injection;|
| Experimental: middle dose dexrazoxane group<br>anthracycline chemotherapy plus middle dose dexrazoxane(15:1) | Drug: Dexrazoxane hydrochloride<br>* pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks<br>* Other names: Dexrazoxane for Injection;Drug: Dexrazoxane hydrochloride<br>* pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks<br>* Other names: dexrazoxane injection;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardioprotection, anthracycline chemotherapy, breast cancer