Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458413
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
Utidelone Capsule Plus Capecitabine CAP for Metastatic Breast Cancer
Sponsor:
Min Yan MD
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
Single-arm Phase II Clinical Trial of Utidelone Capsule Plus Capecitabine CAP in Patients With Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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 aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer and thus provides a new systemic treatment strategy for those patients
This study was a single-arm phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes andor anthracyclines were treated with a combination of utidelone capsules and capecitabine The main objective was to explore the efficacy and safety of the combined regimen
This study was a single-arm phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes andor anthracyclines were treated with a combination of utidelone capsules and capecitabine The main objective was to explore the efficacy and safety of the combined regimen
Detailed Description:
Patients with recurrent or metastatic HER2 negative breast cancer who have previously received chemotherapy containing taxanes andor anthracyclines will receive combined treatment with utidelone capsule and capecitabine Utidelone Capsule 60mgm2d once daily oral on an empty stomach continuously administered for 1-5 days Capecitabine tablets 1000mgm2 twice a day daily dose 2000mgm2 once in the morning and once in the evening taken orally within 30 minutes after meals and continuously administered for 14 days from day 1 to day 14 Every 21 days is a cycle until disease progression intolerable adverse events occur subjects voluntarily withdraw or the researcher determines that medication must be terminated
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