Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

Phase 2TerminatedNCT00955890

Fudan University12 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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