OncoMatch/Clinical Trials/NCT06914440
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
Is NCT06914440 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab and Neoadjuvant Chemotherapy for breast cancer.
Treatment: Toripalimab · Neoadjuvant Chemotherapy · Adjuvant Chemotherapy · Endocrine therapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>1% staining by IHC)
ER-positive (>1% staining) by IHC
Required: PR (PGR) overexpression (>1% staining by IHC)
PR-positive (>1% staining) by IHC
Required: HER2 (ERBB2) negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8) (IHC 0/1+ or FISH ratio ≤1.8)
HER2-negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8)
Required: MKI67 overexpression (≥15%)
Ki-67 ≥15%
Disease stage
Required: Stage IIB, IIIA, IIIB, IIIC
Grade: 23
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antitumor therapy
Exception: within 1 month before enrollment
No prior antitumor therapy within 1 month before enrollment
Cannot have received: systemic targeted therapy
Exception: within 4 weeks before treatment
Prior systemic targeted therapy or immunostimulants (e.g., interferon, IL-2) within 4 weeks before treatment
Cannot have received: immunostimulant (interferon, IL-2)
Exception: within 4 weeks before treatment
Prior systemic targeted therapy or immunostimulants (e.g., interferon, IL-2) within 4 weeks before treatment
Lab requirements
Blood counts
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
Kidney function
bun/cr ≤1.5×uln; cr≥60 ml/min (cockcroft-gault formula)
Liver function
alt/ast ≤2.5×uln; alp ≤2.5×uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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