Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms, Heart Failure
Female
Breast Neoplasms, Heart Failure
Trial Information
Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab
Inclusion Criteria:
- Female 18 years or older
- Histologically confirmed, completely excised invasive breast cancer with Her-2
overexpression
- Primary surgery less than twelve weeks prior to registration
- LVEF>50% as assessed by transthoracic echocardiogram or gated heart pool scan
- Eastern Cooperative Oncology Group Performance Status 0-2
- Adjuvant systemic treatment plan comprises at least three cycles of anthracycline
chemotherapy AND 52 weeks of trastuzumab
- Before patient registration, informed consent must be given according to local
regulations.
Exclusion Criteria:
- Pregnancy
- Distant metastases from breast cancer
- Any systemic chemotherapy prior to study entry
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Cardiotoxicity (Cardiac death; grade 3/4 arrhythmia or ischaemia; NYHA Class 3 or 4 heart failure decline in LVEF by >10% to a level <55%; decline in LVEF by >5% to a level <50%)
Outcome Time Frame:
Until 6 months after completing trastuzumab
Safety Issue:
Yes
Principal Investigator
Jane Beith, MBBS FRACP PhD
Investigator Role:
Study Director
Investigator Affiliation:
Sydney South West Area Health Service (Royal Prince Alfred Hospital)
Authority:
Australia: Human Research Ethics Committee
Study ID:
X08-0296
NCT ID:
NCT00858039
Start Date:
February 2009
Completion Date:
December 2013
Related Keywords:
- Breast Neoplasms
- Heart Failure
- Breast Neoplasms
- Neoplasms
- Heart Failure
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