研究人员正在寻找治疗以下两种类型乳腺癌的新方法： *高风险，这意味著癌症可能有更高的机会恶化或治疗后复发 *早期，这意味著癌症在乳房或乳房周围的淋巴结中本研究中的2种乳腺癌是三阴性乳腺癌（ TNBC ）和激素受体（ HR ） -低阳性/人表皮生长因子受体-2 （ HER2 ）阴性
适应症：Breast Neoplasms、Triple Negative Breast Neoplasms、HR Low-Positive/HER2-Negative Breast Neoplasms
入组条件
纳入标准
- Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:
- cT1c, N1-N2
- cT2, N0-N2
- cT3, N0-N2
- cT4a-d, N0-N2
- The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
- Demonstrates adequate organ function.
排除标准
- Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
- Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
- Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
- Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
- Received prior treatment with a topoisomerase I inhibitor-containing ADC.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- Uncontrolled systemic disease.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。