Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05911958
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-06-12
Brief Title:
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive Low HER2 Expression Breast Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive Low HER2 Expression Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
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:
HR-positive breast cancers accounts for about 50 to 60 of all breast cancer patients Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer and endocrine therapy can be used in some low-risk patients However the pathological complete response pCR rate obtained is low HER2 is an important prognostic indicator and therapeutic target for breast cancer Nearly 60 of HR-positive breast cancers have low expression of HER2 and antibody-drug conjugates ADC targeting HER2 may achieve better efficacy in this subtype
Detailed Description:
This prospective single-arm study is being conducted to evaluate the efficacy and safety of SHR-A1811 for early-stage or locally advanced breast cancer patients with HR-Positive Low HER2 Expression Subjects will receive the neoadjuvant therapy of SHR-A1811 for eight cycles and then undergo surgery within 4 weeks after neoadjuvant therapy The follow-up visit will last for at least 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BC-NEO-IIT-SHR-A1811 | OTHER | Jiangsu Hengrui Medicine CoLtd | None |