Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05430347
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-21
First Post:
2022-06-12
Brief Title:
Clinical Study of Pyrotinib in Neoadjuvant Therapy of HR-positive and HER2-positive Breast Cancer
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Multicenter Phase II Clinical Study of Pyrotinib or Pertuzumab Combined With Docetaxel Carboplatin and Trastuzumab in Neoadjuvant Therapy for HR-positive HER2-positive Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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:
Due to neoadjuvant therapy with trastuzumab and pertuzumab is less effective for HRHER2 breast cancer and the PHEDRA Clinical Study subgroup analysis showed that the addition of pyrotinib to trastuzumab more than doubled pCR rates in HRHER2 patients our research group proposed a hypothesis that pyrotinib may be more advantageous for HRHER2 breast cancer Therefore our center intends to carry out a multi-center randomized controlled prospective clinical study to compare the efficacy of pyrotinib or pertuzumab combined with docetaxel carboplatin and trastuzumab in neoadjuvant therapy for patients with HRHER2 breast cancer and to conduct a comparative study on the safety
Detailed Description:
Different anti-HER2-targeting drugs act on different parts and types of HER2 molecules so their mechanisms and effects are different Trastuzumab and pertuzumab are the most commonly used anti-HER2 targeting drugs which target the extracellular segment of THE HER2 molecule The major guidelines recommend the use of trastuzumab and pertuzumab in the use of neoadjuvant therapy with a two-target regimen Another commonly used class of anti-HER2-targeting drugs are Tyrosine kinase inhibitors TKI which target the intracellular segment of the HER2 molecule Not only that take domestically developed pyrotinib as an example in addition to targeting HER2 it also targets HER1 and HER4 Because of the different mechanisms of action TKI is still effective in patients with trastuzumab andor pertuzumab resistant relapsing metastasis To investigate the efficacy of pyrotinib in neoadjuvant therapy a prospective randomized double-blind multicenter clinical trial the PHEDRA Clinical Study was conducted in China Results presented at the 2021 ASCO Meeting showed that addition of pyrotinib to trastuzumab also significantly increased tpCR rate 220 vs 410 P 00001 and the pCR rate was similar to trastuzumab pertuzumab double target 393 for Neosphere and Peony Based on these results neoadjuvant therapy regimens with trastuzumab and TKI have been included in the 2022 CSCO guidelines
Of note there were also differences in Hormone Receptor HR status in patients with HER2-positive breast cancer After neoadjuvant chemotherapy combined with trastuzumab and pertuzumab double-target therapy the pCR rate of HR-HER2 breast cancer was higher than HRHER2 breast cancer In contrast a PHEDRA subgroup analysis showed that the addition of pyrotinib to trastuzumab more than doubled pCR rates in HRHER2 patients 299 vs 122 In addition in another adjunctive study of TKI drug neratinib subgroup results also suggested that neratinib had a better effect on HRHER2
Based on the above results our research group proposed a hypothesis that TKI drugs may be more advantageous for HRHER2 breast cancer Therefore our center intends to carry out a multi-center randomized controlled prospective clinical study to compare the efficacy of pyrotinib or pertuzumab combined with docetaxel carboplatin and trastuzumab in neoadjuvant therapy for patients with HRHER2 breast cancer and to conduct a comparative study on the safety
Of note there were also differences in Hormone Receptor HR status in patients with HER2-positive breast cancer After neoadjuvant chemotherapy combined with trastuzumab and pertuzumab double-target therapy the pCR rate of HR-HER2 breast cancer was higher than HRHER2 breast cancer In contrast a PHEDRA subgroup analysis showed that the addition of pyrotinib to trastuzumab more than doubled pCR rates in HRHER2 patients 299 vs 122 In addition in another adjunctive study of TKI drug neratinib subgroup results also suggested that neratinib had a better effect on HRHER2
Based on the above results our research group proposed a hypothesis that TKI drugs may be more advantageous for HRHER2 breast cancer Therefore our center intends to carry out a multi-center randomized controlled prospective clinical study to compare the efficacy of pyrotinib or pertuzumab combined with docetaxel carboplatin and trastuzumab in neoadjuvant therapy for patients with HRHER2 breast cancer and to conduct a comparative study on the safety
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