CTIS2023-505928-59-00招募中1 期
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients with Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04) - D926QC00001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,728
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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 tumour 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
排除标准
- •History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence; 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; Known to have active tuberculosis infection; Resting ECG with clinically significant abnormal findings; Uncontrolled or significant cardiac disease; History of non-infectious ILD/pneumonitis; 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.
研究者
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