Although randomized controlled trials (RCTs) provide evidence of efficacy, generalization of these results to patients in the real-world setting is challenging, given RCTs are conducted in highly selected patient populations. An understanding of the effectiveness of approved cancer therapies in routine clinical practice is essential in order to optimize the management of these patients and to identify treatment and monitoring gaps. This is the first Canadian study to describe real-world treatment patterns/sequencing, effectiveness and monitoring for men and pre/postmenopausal HR+ HER2- advanced breast cancer patients. This registry incorporates an observational prospective cohort design and will enroll 500 men and pre/postmenopausal HR+ HER2- advanced breast cancer women that have been exposed to endocrine therapy (ET) or ET in combination with targeted therapy (TT) including patients receiving CDK4/6 inhibitor therapy combinations..
Study Type
OBSERVATIONAL
Enrollment
440
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Burnaby, British Columbia, Canada
Novartis Investigative Site
North Vancouver, British Columbia, Canada
Novartis Investigative Site
Richmond, British Columbia, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Moncton, New Brunswick, Canada
Novartis Investigative Site
Moncton, New Brunswick, Canada
Novartis Investigative Site
Cambridge, Ontario, Canada
Novartis Investigative Site
Kingston, Ontario, Canada
Novartis Investigative Site
Kitchener, Ontario, Canada
...and 15 more locations
Duration on Treatment
To describe the duration on treatment with ET and ET+TT by cohort subgroups defined by (but not limited to) previous treatment with a CDK4/6 inhibitor plus endocrine therapy combination and according to the current line of treatment for advanced breast cancer up to and including 3rd line
Time frame: Up to approximately 24 months
Treatment Sequencing
To describe the sequence of therapies and treatment patterns used for the management of advanced breast cancer.
Time frame: Up to approximately 72 months
Monitoring Patterns
To characterize monitoring patterns associated with complete blood count (CBC), liver function tests (LFT), electrolytes and electrocardiogram (ECG) specifically in patients treated with CDK4/6-based combinations.
Time frame: Up to approximately 72 months
Overall Survival (OS)
To describe the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by OS.
Time frame: Up to approximately 72 months
Health Care Resource Utilization (HCRU)
To describe HCRU related to management of advanced breast cancer.
Time frame: Up to approximately 72 months
Health Related Quality of Life (HRQoL - EORTC QLQ-C30)
To describe the change in HRQoL EORTC 30 questionnaire QLQ-C30
Time frame: Up to approximately 72 months
HRQoL BR23
To describe the change in HRQoL Breast Cancer 23 Questionnaire BR23
Time frame: Up to approximately 72 months
Work-Related Productivity
To describe the change in work-related productivity.
Time frame: Up to approximately 72 months
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