Treatment of Canadian Postmenopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy

Official Title

Treatment of Canadian Postmenopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy

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 and safety of approved cancer therapies in routine clinical practice is essential in order to optimize the management of these patients and to identify treatment and safety gaps. This is the first Canadian study to describe real-world treatment patterns/sequencing, effectiveness and safety for postmenopausal HR+ HER2- advanced breast cancer patients. This registry incorporates an observational prospective cohort design and will enroll 320 postmenopausal HR+ HER2- advanced breast cancer women that have been previously exposed to non-steroidal aromatase inhibitor (NSAI) therapy being treated with endocrine therapy (ET) or ET in combination with targeted therapy (TT).

Trial Description

Primary Outcome:

  • Duration on Treatment
Secondary Outcome:
  • Number of participants with adverse events in ET and ET+TT cohorts
  • Time to Treatment Failure (TTF)
  • Treatment Adherence and Sequencing
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Health Care Resource Utilization (HCRU)
  • Health Related Quality of Life (HRQoL - EORTC QLQ-C30 & -BR23)
  • Work-Related Productivity

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society