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  • The Cardio-Oncology Breast Cancer Study (COBC)
Clinical trial

The Cardio-Oncology Breast Cancer Study (COBC)

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Last updated:1st Jul 2014

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.

Study Type: Interventional

Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Open Label

Primary Purpose: Prevention

Official 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)

Estimated Enrollment: 320

Study Start Date: July 2014

Estimated Study Completion Date: February 2017

Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Arms:

No Intervention: Observational arm
Participants randomized to observational arm will receive standard oncological followup and care.

Experimental: Intervention arm
Intervention arm receives standard oncological followup and care + subclinical cardiotoxicity surveillance and treatment.

Category Value
Study start date 2014-07-01

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