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;
Single group
treatment group
Drug* Albumin-bound paclitaxel; * Carboplatin; * Camrelizumab injection; * Stereotactic Body Radiotherapy; * Epirubicin; * Cyclophosphamide; * Surgery;
pCR(ypT0/Tis ypN0)
Following completion of neoadjuvant systemic therapy, no residual invasive carcinoma was detected in the completely resected breast specimen or in lymph nodes from all sampled regions.
PCR rate among ethnic minority populations
pCR rates based on different definitions of pCR (ypT0/is ypN0, ypT0 ypN0/+, ypT0/is ypN0/+, pCR with no restrictions on ypT and ypN0)
Objective Response Rate (ORR)
Breast-conserving surgery rate
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