Breast Cancer Clinical Trial
— COBCOfficial title:
Effects of Identifying and Treating Early, Subclinical Cardiotoxicity on the Long-Term Incidence of Clinical Cardiotoxicity in Women With Breast Cancer, A Prospective Randomized Study: The Cardio-Oncology Breast Cancer Study (COBC)
Verified date | March 2018 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this randomized controlled trial is to test the association between standard cardiac risk factors, biomarkers and parameters of echocardiography, electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent occurrence, frequency and severity of clinical or subclinical cardiotoxicity (outcome) within and between-groups, before start of chemotherapy, during treatment and at 1, 5, and 10 years after the completion of the chemotherapy among women with early breast cancer.
Status | Active, not recruiting |
Enrollment | 320 |
Est. completion date | February 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women with newly diagnosed breast cancer who are eligible to receive neo-adjuvant or adjuvant chemotherapy, with or without trastuzumab, according to the guidelines for breast cancer. - Written informed consent must be given. Exclusion Criteria: - A history of heart disease; ischemic heart disease, arrhythmias, heart failure, and valve diseases. - Previously received oncological treatment for any malignancy. - Other disease or conditions that complicates or precludes the patient from following the study protocol. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital |
Sweden,
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event free survival | The cumulative incidence of clinical or subclinical cardiotoxicity, per randomized arm, in women with breast cancer at 1 year after treatment with neo- or adjuvant chemotherapy. | 1 year after the completion of the chemotherapy. | |
Secondary | Event free survival | 5 and 10 years after the completion of the chemotherapy. | ||
Secondary | Overall survival | 1, 5 and 10 years after the completion of the chemotherapy. | ||
Secondary | The levels of serum biomarkers (hs-Troponin T (hs-TnT), B-type natriuretic peptide (BNP)). | 1, 5 and 10 years after the completion of the chemotherapy. | ||
Secondary | Echocardiographic global longitudinal strain | 1, 5 and 10 years after the completion of the chemotherapy. | ||
Secondary | The quality of life | 1, 5 and 10 years after the completion of the chemotherapy. |
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