OncoMatch/Clinical Trials/NCT06611813
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)
Is NCT06611813 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Neoadjuvant Chemotherapy in Combination with Toripalimab and HR+ HER2 breast cancer for hr+/her2- breast cancer.
Treatment: Neoadjuvant Chemotherapy in Combination with Toripalimab · HR+ HER2 breast cancer — This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (positive)
ER/PR positive
Required: PR (PGR) overexpression (positive)
ER/PR positive
Required: HER2 (ERBB2) wild-type (negative)
HER2 negative
Required: PD-L1 (CD274) expression
Pathological examination of PD-L1 expression: The Combined Positive Score (CPS)...detected the PD-L1 antibody site as 22C3.
Disease stage
Excluded: Stage IV
tumor diameter>1cm (T1c-3; N0-3; M0). Stage IV breast cancer [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor treatment
Exception: excluding those that have been cured malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.
Lab requirements
Blood counts
ANC > 1.5 × 10^9/L; PLT > 75 × 10^9/L; Hb > 90g/L; Lymphocyte count ≥ 1.5 × 10^9/L
Kidney function
BUN/UREA and creatinine (Cr) < 1.5 × ULN
Liver function
Total bilirubin (TBIL) < 1.5 × ULN; ALT and AST < 1.5 × ULN; Alkaline phosphatase < 2.5 × ULN
Cardiac function
LVEF > 55%; QTcF < 470 ms
Blood routine: ANC > 1.5 × 10^9/L; PLT > 75 × 10^9/L; Hb > 90g/L; Lymphocyte count ≥ 1.5 × 10^9/L. Blood biochemistry: TBIL < 1.5 × ULN; ALT and AST < 1.5 × ULN; Alkaline phosphatase < 2.5 × ULN; BUN/UREA and Cr < 1.5 × ULN. Cardiac ultrasound: LVEF > 55%. 12 lead ECG: QTcF < 470 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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