OncoMatch/Clinical Trials/NCT06313463
Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy
Is NCT06313463 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Carrellizumab + Capecitabine for breast neoplasms.
Treatment: Carrellizumab + Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression
Confirmation of TNBC diagnosis and TLS and PD-L1 status through central examination of representative tumor tissue specimens resected during surgery.
Disease stage
Required: Stage CT4/ANY N/M0, ANY CT/N2-3/M0, CT1-3/N0-1/M0
Excluded: Stage CT1MI/T1A/T1B/N0, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic chemotherapy — neoadjuvant
Completion of preoperative systemic chemotherapy and camrelizumab treatment.
Must have received: anti-PD-1 therapy (camrelizumab) — neoadjuvant
Completion of preoperative systemic chemotherapy and camrelizumab treatment.
Cannot have received: CD137 agonist
Prior use of CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T-lymphocyte-associated protein 4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
Cannot have received: immune checkpoint inhibitor (anti-CTLA-4, anti-PD-1, anti-PD-L1)
Exception: camrelizumab in neoadjuvant setting allowed
Prior use of CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T-lymphocyte-associated protein 4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
LVEF ≥50% during screening and ≤15% decrease from pre-chemotherapy LVEF, or if no pre-chemotherapy LVEF, then LVEF ≥55% during screening
Adequate hematological and organ function. Completion of neoadjuvant therapy with echocardiography or multi-gated acquisition scan showing left ventricular ejection fraction (LVEF) ≥50% during the screening period and an absolute decrease in LVEF compared to pre-chemotherapy LVEF not exceeding 15%. Alternatively, if LVEF assessment was not performed pre-chemotherapy, LVEF must be ≥55% during the screening period post-neoadjuvant therapy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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