Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer: A Single-arm, Prospective Clinical Trial
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negative breast cancer.
• Female patients aged ≥18 and ≤75 years at the time of signing informed consent.
• ECOG PS status of 0-1.
• Breast cancer assessed as non-metastatic (M0), meeting all of the following:
‣ Clinical stage: Stage IIB, IIIA, IIIB, or IIIC
⁃ Required imaging assessments (within 28 days): Abdominal CT, ECT Bone scan, Chest CT and Brain MRI
• Histologically or pathologically confirmed invasive carcinoma of no special type, with all of the following:
‣ Grade 2 or 3 (confirmed by central laboratory);
⁃ ER-positive (\>1% staining) and/or PR-positive (\>1% staining) by IHC;
⁃ HER2-negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8);
⁃ Ki-67 ≥15%.
• Patient deemed eligible for radiotherapy after MDT evaluation.
• No prior antitumor therapy within 1 month before enrollment.
• Organ Function Requirements (within 7 days prior to enrollment):
‣ Complete blood count (no transfusion or hematopoietic growth factors within 7 days): ANC ≥1.5×10⁹/L; ALC ≥0.5×10⁹/L; Platelets ≥100×10⁹/L; Hemoglobin ≥90 g/L; WBC ≥3.0×10⁹/L and ≤15×10⁹/L;
⁃ Blood biochemistry (no transfusion/albumin within 7 days): ALT/AST ≤2.5×ULN; ALP ≤2.5×ULN;BUN/Cr ≤1.5×ULN; Cr≥60 mL/min (Cockcroft-Gault formula);
⁃ Coagulation: PT/APTT ≤1.5×ULN; INR ≤1.5×ULN (if no anticoagulant therapy);
⁃ Urinalysis: Urine protein \<2+; if ≥2+, 24-hour urine protein must be ≤1g;
⁃ Thyroid function:TSH ≤1×ULN; if abnormal, normal T3/T4 levels required for eligibility.
• Women of childbearing potential must:
‣ Have a negative serum pregnancy test within 7 days before treatment;
⁃ Use highly effective contraception during the study and for 180 days after the last dose.
• Voluntarily sign informed consent, demonstrate good compliance, and commit to follow-up.