NCT06313463

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Carrellizumab + Capecitabine	Capecitabine 1000-1250mg/m2 PO bid D1-14（Q3W）+ Carrellizumab 200mg IV D1（Q3W），8 cycles in total
DRUG	Placebo + Capecitabine	Capecitabine 1000-1250mg/m2 PO bid D1-14（Q3W）+ Placebo 200mg IV D1（Q3W），8 cycles in total

Timeline

• Start date: 2024-03-01
• Primary completion: 2031-09-01
• Completion: 2035-12-01
• First posted: 2024-03-15
• Last updated: 2024-03-15

Locations

1 site across 1 country: China