Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Dexrazoxane hydrochloride

• Registration Number: NCT00955890
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose dexrazoxane group	Dexrazoxane hydrochloride	anthracycline chemotherapy plus low dose dexrazoxane(10:1)
middle dose dexrazoxane group	Dexrazoxane hydrochloride	anthracycline chemotherapy plus middle dose dexrazoxane(15:1)

Primary Outcome Measures

Name	Time	Method
Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China