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

Fudan University

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Dexrazoxane hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00955890

MBC0901 FUCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

control arm

No Intervention group

Description:

anthracycline chemotherapy only

low dose dexrazoxane group

Experimental group

Description:

anthracycline chemotherapy plus low dose dexrazoxane(10:1)

Treatment:

Drug: Dexrazoxane hydrochloride

Drug: Dexrazoxane hydrochloride

middle dose dexrazoxane group

Experimental group

Description:

anthracycline chemotherapy plus middle dose dexrazoxane(15:1)

Treatment:

Drug: Dexrazoxane hydrochloride

Drug: Dexrazoxane hydrochloride