癌研連線CancerLink
进行中（不再招募） NCT05382299

Sacituzumab Govitecan-hziy 对比研究者选择治疗用于既往未接受治疗的局部晚期不可手术或转移性三阴性乳腺癌患者的研究

乳腺癌肉瘤Phase IIII 期III 期IV 期PD-L1

本研究的主要目标是比较 sacituzumab govitecan-hziy（SG）与研究者选择治疗（TPC）在既往未接受治疗、局部晚期、不可手术或转移性三阴性乳腺癌参与者中的无进展生存期（PFS），该等参与者的肿瘤不表达程序性细胞死亡配体1（PD-L1），或参与者既往曾接受抗程序性细胞死亡（配体或蛋白）1（Anti-PD-(L)1）治疗。

适应症：Triple Negative Breast Cancer、PD-L1 Negative

入组条件

纳入标准

  • Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
  • Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
  • Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
  • Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
  • Individuals presenting with de novo metastatic TNBC are eligible
  • Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Demonstrates adequate organ function
  • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
  • Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease

排除标准

  • Positive serum pregnancy test or women who are lactating
  • Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
  • Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
  • May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
  • Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
  • Active second malignancy
  • Active serious infection requiring antibiotics
  • Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

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。