Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00955890

Acronym

cardioprotec

Enrollment

Registered

2009-08-10

Start date

2009-06-30

Completion date

2012-02-29

Last updated

2012-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

cardioprotection, anthracycline chemotherapy, breast cancer

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.

Interventions

DRUGDexrazoxane hydrochloride

pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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)

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026