Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05843292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-06
First Post:
2023-04-25
Brief Title:
Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer an Open-labeled Single Arm Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
NeoSTEP
Brief Summary:
The goal of this clinical trial is to learn about the efficacy and safety of short-term sintilimab in combination with taxane and carboplatin for neoadjuvant therapy in female early-stage triple-negative breast caner patients aging from 18 to 70 years with unilateral and invasive primary lesions above 1cm The main questions it aims to answer are
1 Does short-term sintilimab in combination with taxane and carboplatin lead to acceptible pathological complete response pCR rates objective response rates ORR event-free survival EFS and overall survival OS
2 Does short-term sintilimab in combination with taxane and carboplatin lead to less adverse events than regular-term ICIs reported in literature
Participants will be given 2 cycles of sintilimab in combination with 4 cycles of taxane and carboplatin before surgery An optional core-needle biopsy is performed after completing 2 cycles of sintilimab All participants will be given regular follow-up post surgery according to ASCO guidelines
1 Does short-term sintilimab in combination with taxane and carboplatin lead to acceptible pathological complete response pCR rates objective response rates ORR event-free survival EFS and overall survival OS
2 Does short-term sintilimab in combination with taxane and carboplatin lead to less adverse events than regular-term ICIs reported in literature
Participants will be given 2 cycles of sintilimab in combination with 4 cycles of taxane and carboplatin before surgery An optional core-needle biopsy is performed after completing 2 cycles of sintilimab All participants will be given regular follow-up post surgery according to ASCO guidelines
Detailed Description:
None
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