Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-11-14
Brief Title:
Darsilide Combined With AI Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HRHER2 Breast Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
A Clinical Study of Darsilide Combined With AI Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR Positive HER2 Positive Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 intended to carry out a single arm prospective open clinical study and use Darsilide combined with endocrine therapy Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy
Detailed Description:
This study is intended to carry out a single arm prospective open clinical study and use Darsilide combined with endocrine therapy Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy
All participants received 150mg of darcilib once a day Take it continuously for 21 days then stop taking it for 7 days with a treatment cycle of 28 daysLetrozole 25mg once daily premenopausal patients treated with OFSTrastuzumab 8mgkg first dose 6mgkg sequential and Patuzumab 840mg first dose 420mgkg sequential were administered intravenously every 3 weeks with all patients receiving 6 cycles of treatment After starting treatment and before surgery subjects will be monitored through breast MRI to evaluate clinical tumor remission The primary endpoint was the pCR rate in the group receiving darcilibletrozoleHP treatment defined as the proportion of patients who achieved pCR after surgery after neoadjuvant therapy
All participants received 150mg of darcilib once a day Take it continuously for 21 days then stop taking it for 7 days with a treatment cycle of 28 daysLetrozole 25mg once daily premenopausal patients treated with OFSTrastuzumab 8mgkg first dose 6mgkg sequential and Patuzumab 840mg first dose 420mgkg sequential were administered intravenously every 3 weeks with all patients receiving 6 cycles of treatment After starting treatment and before surgery subjects will be monitored through breast MRI to evaluate clinical tumor remission The primary endpoint was the pCR rate in the group receiving darcilibletrozoleHP treatment defined as the proportion of patients who achieved pCR after surgery after neoadjuvant therapy
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