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).
Female patients aged ≥18 years and ≤75 years with treatment-naive breast cancer;
Histopathologically confirmed early-stage triple-negative invasive breast cancer as defined by the latest ASCO/CAP guidelines, meeting all of the following criteria: Pathological subtype must be triple-negative, specifically: ER-negative: IHC <1%, PR-negative: IHC <1%, HER2-negative: IHC 0/1+ or IHC 2+ but ISH-negative;
Primary triple-negative breast cancer patients with clinical staging cT1c-T4d and any cN status;
Center-assessed Ki67 and sTIL values;
Tumor-Related Symptoms and Treatments
Patients with metastatic breast cancer or bilateral breast cancer;
Patients with inflammatory breast cancer;
Received any antitumor therapy within 12 months prior to signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy, or tumor embolization;