NCT07491822

A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Camrelizumab + Chemoradiotherapy for Early TNBC Sponsor/Leading Center: Tianjin Medical University Cancer Institute and Hospital Study Type: Single-arm, single-center, Phase Ⅱ clinical study Planned Enrollment: 43 patients Eligible Population 18-75-year-old female patients with newly diagnosed, untreated early invasive triple-negative breast cancer (TNBC) (ER-/PR-/HER2- per ASCO/CAP guidelines), clinical stage cT1c-T4d (any cN); central assessment of Ki67 and sTIL values, at least one measurable lesion (RECIST 1.1), normal major organ function, expected survival ≥3 months; negative pregnancy test (women of childbearing potential) with agreement to effective contraception; signed informed consent and good compliance. Exclusion: Metastatic/bilateral/inflammatory TNBC; prior anti-tumor/PD-1/PD-L1 treatment within 12 months; active other malignancies, autoimmune diseases, interstitial lung disease, uncontrolled severe infections/heart disease; pregnancy/lactation; allergy to study drugs. Study Design Treatment Regimen (Neoadjuvant + Individualized Follow-up) All patients receive the same combined therapy, followed by surgery (with extended treatment for non-responders): 12-week core neoadjuvant treatment: Camrelizumab (200mg IV, Q3W) + nab-paclitaxel (100mg/m² IV, weekly) + carboplatin (AUC=1 IV, weekly) + SBRT (10Gy × 2 sessions, on the 3rd day after chemotherapy in Week 3 and 6). Post-12-week evaluation \& treatment: Clinical responders: Undergo surgery within 3 weeks. Clinical non-responders: Continue with 12-week EC regimen (epirubicin 80mg/m² + cyclophosphamide 600mg/m², IV Q3W, 4 cycles) + camrelizumab, then surgery within 3 weeks. Study Procedures Screening (≤28 days): Complete imaging, laboratory and physical examinations to confirm eligibility. Treatment period: Scheduled combined therapy with regular efficacy assessments (breast imaging every 2 cycles) and safety monitoring. Follow-up: Mandatory surgery after treatment; 90-day safety follow-up post-last dose, and long-term survival follow-up (q3m for Year 1, q6m thereafter) for 5 years. Primary Outcome Pathological complete response (pCR, defined as ypT0/Tis ypN0: no residual invasive cancer in resected breast and sampled lymph nodes).

Conditions

• TNBC

Interventions

Type	Name	Description
DRUG	treatment group	* Albumin-bound paclitaxel; * Carboplatin; * Camrelizumab injection; * Stereotactic Body Radiotherapy; * Epirubicin; * Cyclophosphamide; * Surgery;

Timeline

• Start date: 2026-03-25
• Primary completion: 2027-09-15
• Completion: 2031-03-15
• First posted: 2026-03-24
• Last updated: 2026-03-24