Treatment of Canadian Men and Pre/Peri/Post-menopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy

Completed

• Conditions: HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer

• Registration Number: NCT02753686
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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..

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-15
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration on Treatment	Up to approximately 24 months	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

Secondary Outcome Measures

Name	Time	Method
HRQoL BR23	Up to approximately 72 months	To describe the change in HRQoL Breast Cancer 23 Questionnaire BR23
Treatment Sequencing	Up to approximately 72 months	To describe the sequence of therapies and treatment patterns used for the management of advanced breast cancer.
Health Care Resource Utilization (HCRU)	Up to approximately 72 months	To describe HCRU related to management of advanced breast cancer.
Overall Survival (OS)	Up to approximately 72 months	To describe the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by OS.
Health Related Quality of Life (HRQoL - EORTC QLQ-C30)	Up to approximately 72 months	To describe the change in HRQoL EORTC 30 questionnaire QLQ-C30
Monitoring Patterns	Up to approximately 72 months	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.
Work-Related Productivity	Up to approximately 72 months	To describe the change in work-related productivity.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇦 Quebec, Canada