Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313463
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-06
Brief Title:
Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy
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 Randomized Double-blind Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Camrelizumab and Capecitabine Versus Capecitabine as Adjuvant Therapy in Early-stage Triple-negative Breast Cancer Patients With Tertiary Lymphoid Structure in Tumor Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Neoadjuvant Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer TNBC who have not achieved pathological complete response pCR after neoadjuvant chemotherapy and have tertiary lymphoid structures TLS in the tumor tissue The primary endpoint of this study is disease-free survival DFS to assess the long-term effectiveness of the treatment Secondary endpoints include invasive disease- free survival IDFS overall survival OS distant recurrence-free interval DRFI as well as safety and patient-reported outcomes These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients
The study anticipates a total sample size of 375 patients who will be randomly assigned to either the experimental group or the control group The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy
The study anticipates a total sample size of 375 patients who will be randomly assigned to either the experimental group or the control group The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy
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