Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945368
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-05-28
Brief Title:
A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Prospective Single-arm Phase II Trial of Eribulin in Combination With Trastuzumab and Pertuzumab for Neoadjuvant Therapy HER2-Positive Early or Locally Advanced Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-07
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:
To evaluate the pathology complete response rate pathology Complete Response pCR of eribulin combined with trastuzumab pertuzumab in neoadjuvant therapy for HER-2 positive early or locally advanced breast cancer
Detailed Description:
Breast cancer with positive HER-2 is sensitive to chemotherapy and targeted therapy and double-target regimen containing trastuzumab and pertuzumab is the preferred regimen no matter in neoadjuvant adjuvant or advanced first-line stage A series of clinical studies have established the strong position of trastuzumab pertuzumab in the neoadjuvant therapy of HER2-positive breast cancer but it is still unclear which chemotherapy drugs have the best efficacy when combined with them Eribulin mesylate is a potent microtubule inhibitor It is used as a single agent for the treatment of locally relapsed or metastatic breast cancer that has been treated with at least two chemotherapy regimens in the past because of its good therapeutic effect and small toxic side effects The role of advanced breast cancer treatment is increasingly prominent Therefore the investigators plan to conduct clinical studies to evaluate the efficacy and safety of Eribulin combined with trastuzumab and pertuzumab in neoadjuvant therapy for HER-2 positive breast cancer so as to provide better treatment options for neoadjuvant chemotherapy for HER-2 positive breast cancer The investigators expect that Erribulin combined with trastuzumab and pertuzumab can achieve comparable results If the pCR rate in this study reaches 40 follow-up randomized controlled studies will be considered
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