癌研連線CancerLink
进行中（不再招募） NCT06112379

一项第三期随机研究，评估 Dato-DXd 及 durvalumab 用于三阴性或激素受体低表达/HER2阴性乳腺癌的新辅助/辅助治疗

乳腺癌Phase IIIII 期HER2PD-L1

这是一项第三期、两臂、随机、开放标签、多中心、全球性研究，评估新辅助 Dato-DXd 加 durvalumab 继以辅助 durvalumab 合并或不合并化疗，相较于新辅助 pembrolizumab 加化疗继以辅助 pembrolizumab 合并或不合并化疗，用于既往未经治疗的三阴性乳腺癌或激素受体低表达/HER2阴性乳腺癌参与者的疗效及安全性。

适应症：Breast Cancer

入组条件

纳入标准

  • Participant must be ≥ 18 years, at the time of signing the ICF.
  • Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
  • ECOG PS of 0 or 1
  • Provision of acceptable tumor sample
  • Adequate bone marrow reserve and organ function
  • Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and aligned with protocol requirements.

排除标准

  • History of any prior invasive breast malignancy
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 5 years before randomization.
  • active or prior documented autoimmune or inflammatory disorders.
  • Evidence of distant disease.
  • Clinically significant corneal disease.
  • Has active or uncontrolled hepatitis B or C virus infection.
  • Known HIV infection that is not well controlled.
  • Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
  • Known to have active tuberculosis infection
  • Mean resting corrected QTcF interval \> 470 ms obtained from ECG
  • Uncontrolled or significant cardiac disease.
  • History of non-infectious ILD/pneumonitis
  • Has severe pulmonary function compromise
  • Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
  • For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
  • Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.
  • Concurrent use of systemic hormone replacement therapy or oral hormonal contraception

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。