Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548919
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Current Status of Treatment for Chinese Patients With ESR1-mutated HRHER2-advanced Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness and Safety of Different Treatment Regimens in Patients With ESR1-mutated HRHER2-advanced Breast Cancer After Failure of Prior Endocrine Therapy a Prospective Non-interventional Real-world Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HRHER2-advanced breast cancer after failure of endocrine therapy
Epidemiological data efficacy and safety measures will be collected for each subject Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression receipt of a new anti-tumour treatment modality death loss to follow-up and arrival at the data collection cut-off date The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject or 4 weeks after treatment discontinuation and subject discontinuationwithdrawal Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen
Epidemiological data efficacy and safety measures will be collected for each subject Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression receipt of a new anti-tumour treatment modality death loss to follow-up and arrival at the data collection cut-off date The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject or 4 weeks after treatment discontinuation and subject discontinuationwithdrawal Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None