Cardiotoxicity of Adjuvant Trastuzumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-06-30

Brief Summary

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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 trastuzumab are known to cause cardiac dysfunction in a proportion of patients. Patients who develop heart problems when taking trastuzumab might have to stop this treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of which have been shown to indicate the presence of heart failure. Some early research has suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to cancer chemotherapy and also trastuzumab. Troponin is another substance measured in the blood that can indicate heart damage. Finally, certain variations in an individual's genetic makeup (called polymorphisms) could put them at increased risk of heart damage from trastuzumab. Here we are studying whether any of these factors (NT pro-BNP levels, troponin levels, or certain genetic polymorphisms) can accurately predict who is at highest risk of trastuzumab-related cardiotoxicity.

The principal aim of this study is to evaluate the utility of NT pro-BNP as a predictive biomarker for the development of trastuzumab related cardiotoxicity (TRC). The investigators will also examine if single nucleotide polymorphisms in the HER2 gene or Fc-gamma-receptor genes predict for TRC.

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Detailed Description

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Conditions

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Breast Neoplasms Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Her-2 positive ESBC

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Shom Goel

Breast Oncology Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jane Beith, MBBS FRACP PhD

Role: STUDY_DIRECTOR

Sydney South West Area Health Service (Royal Prince Alfred Hospital)

Locations

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