OncoMatch/Clinical Trials/NCT06977893
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)
Is NCT06977893 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Neoadjuvant Chemotherapy in Combination with Toripalimab and Neoadjuvant Chemotherapy for hr+/her2- breast cancer.
Treatment: Neoadjuvant Chemotherapy in Combination with Toripalimab · Neoadjuvant Chemotherapy — Our center plans to conduct a randomized, open-label, parallel-controlled, multi-center phase III study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Toripalimab for HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy with immunotherapy for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 positive (ER positive)
ER/PR positive
Required: PR (PGR) positive (PR positive)
ER/PR positive
Required: HER2 (ERBB2) negative (HER2 negative)
HER2 negative
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
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)
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 < 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 creatinine < 1.5 × ULN. Cardiac ultrasound: LVEF > 55%. 12 lead electrocardiogram: QTcF < 470 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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