Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04929548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-01-05
First Post:
2021-06-08
Brief Title:
Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP
Sponsor:
Wuhan University
Organization:
Wuhan University
Study Overview
Official Title:
Exploratory Study of Triple-targeted Neoadjuvant Treatment of HER2-positive Breast Cancer With Pyrotinib in Combination With Trastuzumab and Pertuzumab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-01
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 single-arm single-center exploratory clinical study Twenty patients with early-stage HER2-positive breast cancer are planned to be included and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab pertuzumab
Detailed Description:
Recruiting patients with clinical stage II to III HER2-positive breast cancer for primary treatment eligible subjects will be enrolled as follows This study is a single-arm single-center exploratory clinical study Twenty patients with early-stage HER2-positive breast cancer are planned to be included and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab pertuzumabEligible subjects who met the enrollment criteria and signed the informed consent form entered the trial period and received epirubicin 100 mgm2 iv cyclophosphamide 600 mgm2 iv Pyrotinib 400 mgd po for 4 weeks sequential docetaxel 80 mgm2 iv trastuzumab 6 mgkg first dose 8 mgkg iv pertuzumab 420 mg first dose 840 mg iv po 4 cycles of treatment Surgery was performed at the end of the above treatment cycles and adjuvant targeted therapy was continued after surgery trastuzumab patuximab for 1 year
Eligible subjects 20 who met the nadir criteria and signed the informed consent form entered the trial period and received the ECPy-THP regimen ie epirubicin 100 mgm2 iv cyclophosphamide 600 mgm2 iv Pyrotinib 400 mgd po 4 cycles sequential docetaxel 80 mgm2 iv trastuzumab 6 mgkg first dose 8 mgkg iv patuximab 420 mg first dose 840 mg iv po 4 cycles of treatment If the efficacy of 4 cycles was evaluated as PD or SD the regimen was promptly adjusted for surgical treatment
Surgery was performed at the end of the above treatment cycles and adjuvant targeted therapy was continued after surgery patients who reached pCR continued trastuzumab pertuzumab for 1 year and non-pCR patients were treated according to the guideline-recommended backline regimen
All patients underwent surgery or radiotherapy continuation within 16-20 d after completion of the neoadjuvant chemotherapy cycle and the efficacy was assessed 1 to 2 d before continuation of treatment
Eligible subjects 20 who met the nadir criteria and signed the informed consent form entered the trial period and received the ECPy-THP regimen ie epirubicin 100 mgm2 iv cyclophosphamide 600 mgm2 iv Pyrotinib 400 mgd po 4 cycles sequential docetaxel 80 mgm2 iv trastuzumab 6 mgkg first dose 8 mgkg iv patuximab 420 mg first dose 840 mg iv po 4 cycles of treatment If the efficacy of 4 cycles was evaluated as PD or SD the regimen was promptly adjusted for surgical treatment
Surgery was performed at the end of the above treatment cycles and adjuvant targeted therapy was continued after surgery patients who reached pCR continued trastuzumab pertuzumab for 1 year and non-pCR patients were treated according to the guideline-recommended backline regimen
All patients underwent surgery or radiotherapy continuation within 16-20 d after completion of the neoadjuvant chemotherapy cycle and the efficacy was assessed 1 to 2 d before continuation of treatment
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