Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05578053
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-10-13
First Post:
2022-10-10
Brief Title:
Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer
Sponsor:
Hebei Medical University Fourth Hospital
Organization:
Hebei Medical University Fourth Hospital
Study Overview
Official Title:
Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer a Multicenter Observational Real-world Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-10
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:
None
Brief Summary:
This study is a multi-center observational real-world study We planned to recruit 420 HR locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions completely following the physician s clinical choice to assess the efficacy and safety of dalpiciclib-containing regimens
Detailed Description:
All patients included in the analysis were receiving or were planning to receive dalpiciclib and other standard therapy with no restrictions on the regimen and full adherence to physician clinical choices Patients who qualified after completing the screening tests and assessments entered the study treatment period and were treated and visited with a dalpiciclib -containing regimen as specified in the protocol Patients underwent imaging assessments and safety assessments according to clinical routine during study treatment with the investigator s assessment as the final result
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