癌研連線CancerLink
進行中（不再收案） NCT06112379

一項第三期隨機研究，評估 Dato-DXd 及 durvalumab 用於三陰性或荷爾蒙受體低表達/HER2陰性乳癌的新輔助/輔助治療

乳癌Phase IIIII 期HER2PD-L1

這是一項第三期、兩臂、隨機、開放標籤、多中心、全球性研究，評估新輔助 Dato-DXd 加 durvalumab 繼以輔助 durvalumab 合併或不合併化療，相較於新輔助 pembrolizumab 加化療繼以輔助 pembrolizumab 合併或不合併化療，用於既往未經治療的三陰性乳癌或荷爾蒙受體低表達/HER2陰性乳癌參與者的療效及安全性。

適應症：Breast Cancer

收案條件

納入條件

  • 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.

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。