Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02753686
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2016-04-20
Brief Title:
Treatment of Canadian Men and PrePeriPost-menopausal Women With ER Advanced Breast Cancer in the Real-World Setting With Hormone Therapy Targeted Therapy
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Treatment of Canadian Men and PrePostmenopausal Women With ER Advanced Breast Cancer in the Real-World Setting With Hormone Therapy Targeted Therapy
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Treat ERight
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 patternssequencing effectiveness and monitoring for men and prepostmenopausal HR HER2- advanced breast cancer patients This registry incorporates an observational prospective cohort design and will enroll 500 men and prepostmenopausal 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 CDK46 inhibitor therapy combinations
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 patternssequencing effectiveness and monitoring for men and prepostmenopausal HR HER2- advanced breast cancer patients This registry incorporates an observational prospective cohort design and will enroll 500 men and prepostmenopausal 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 CDK46 inhibitor therapy combinations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None