OncoMatch/Clinical Trials/NCT06874933
Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)
Is NCT06874933 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart for hr+/her2- breast cancer.
Treatment: Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart — Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation 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 overexpression (ER+ ≥1% by IHC) (≥1%)
Immunohistochemical staining results confirm ER+ (≥1%)
Required: HER2 (ERBB2) negative (FISH ratio ≤ 1.8 or IHC 0 or 1+) (FISH ratio ≤ 1.8 or IHC 0 or 1+)
HER2 negative (Her2/neu fluorescence in situ hybridization (FISH) ratio ≤ 1.8 or IHC 0 or 1+)
Required: PD-L1 (CD274) expression (CPS ≥ 10 by 22C3 antibody) (CPS ≥ 10)
the combined positive score (CPS) is greater than or equal to 10 points. The PD-L1 antibody site detected in our center is 22C3.
Disease stage
Required: Stage T1C (≥1 CM) - 4C N0-2
Excluded: Stage IV
Grade: 3
T1c (≥1 cm) - 4c N0-2; Histologically confirmed as grade 3 by the research center
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor treatment
Exception: excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma
Have previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma
Lab requirements
Blood counts
ANC > 1.5×10⁹/L; platelet count > 75×10⁹/L; hemoglobin > 90 g/L; lymphocyte count ≥ 1.5×10⁹/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 msec
The functional levels of the major organs must meet the following requirements (no blood transfusion, and no use of drugs for increasing white blood cells or platelets within 2 weeks before screening): 1. Blood routine: Absolute neutrophil count (ANC) > 1.5×10⁹/L; platelet count (PLT) > 75× 10⁹/L; hemoglobin (Hb) > 90 g/L; lymphocyte count ≥ 1.5×10⁹/L. 2. Blood biochemistry: Total bilirubin (TBIL) < 1.5× ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5×ULN; alkaline phosphatase < 2.5×ULN; blood urea nitrogen/urea (BUN/UREA) and creatinine (Cr) < 1.5×ULN. 3. Echocardiogram: Left ventricular ejection fraction (LVEF) > 55%. 4. 12-lead electrocardiogram: The corrected QT interval using the Fridericia method (QTcF) < 470 msec.
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