Status:
COMPLETED
Cardiotoxicity of Adjuvant Trastuzumab
Lead Sponsor:
Royal Prince Alfred Hospital, Sydney, Australia
Conditions:
Breast Neoplasms
Heart Failure
Eligibility:
FEMALE
18+ years
Brief Summary
Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting (anthracyclines) and t...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Distant metastases from breast cancer
- Any systemic chemotherapy prior to study entry
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00858039
Start Date
February 1 2009
End Date
June 1 2014
Last Update
November 5 2014
Active Locations (15)
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1
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
2
Royal North Shore Private Hospital
Sydney, New South Wales, Australia, 2065
3
Sydney Haematology Oncology Clinic
Sydney, New South Wales, Australia, 2077
4
Concord Hospital
Sydney, New South Wales, Australia, 2137