Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639672
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Neoadjuvant Chemotherapy PD-1 InhibitorDifferent Radiotherapy Fractionations for HRHER2- Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HRHER2- Breast Cancer A Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For the hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- subtype of breast cancer although surgical radiotherapy and endocrine treatments have shown better survival this subtype has a relatively poor response to neoadjuvant chemotherapy and immunotherapy with an approximately pCR of 20 The low immunogenicity result in suboptimal pCR and objective response rates for this group Therefore there is an urgent need to explore new highly effective and low-toxicity treatment strategies to further improve the efficacy of HRHER2- breast cancer Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells enhancing T-cell infiltration and directly killing tumor cells Therefore this study aims to investigate the efficacy and safety of chemotherapy combined with PD-1 inhibitor and different radiotherapy fractionations in the neoadjuvant treatment of HRHER2- breast cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None