Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy - Trial NCT06313463

Timeline & Enrollment

Primary Outcome

Disease-Free Survival

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.

ICD-10 Classifications