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

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), dis

Trial Details

NCT ID
NCT06313463
Phase
PHASE3
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Carrellizumab + Capecitabine
  • Placebo + Capecitabine
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Signed informed consent form.
  • Female patients aged ≥18 years at the time of signing informed consent.
  • Patients with adequate cognitive ability and willingness to understand and comply with the treatment and follow-up plans as required by the study p…
  • Confirmed invasive breast cancer on histological examination.

For full eligibility, visit ClinicalTrials.gov.

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