Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

Breast Cancer Clinical Trial

— cardioprotec  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00955890
• Other study ID #: MBC0901 FUCH
• Status: Terminated
• Phase: Phase 2
• First received: August 7, 2009
• Last updated: February 27, 2012
• Start date: June 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Dexrazoxane hydrochloride
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
• Dexrazoxane hydrochloride
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy		1 year	Yes
Secondary	Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity		1 year	Yes