Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627712
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Stereotactic Body Radiotherapy SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage Treatment-naive Triple-negative Breast Cancer Patients A Multicenter Phase III Clinical 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:
Triple-negative breast cancer TNBC presents significant challenges due to its limited treatment options and poor efficacy While neoadjuvant chemotherapy has improved breast-conserving rates and extended survival for TNBC patients this subtype still faces issues such as restricted treatment modalities low pathological response rates and unfavorable prognosis compared to other subtypes Studies like Keynote522 and IMpassion031 have shown that combining chemotherapy with immunotherapy yields a pCR rate of 648 in early-stage high-risk TNBC patients suggesting that such combinations can offer substantial benefits However the low immunogenicity of breast cancer and the lack of clear predictive molecular markers for effective immunotherapy result in suboptimal pCR and objective response rates for this group 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 stereotactic radiotherapy combined with PD-1 inhibitors and chemotherapy in the neoadjuvant treatment of TNBC
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