2024-511204-16-00招募中3 期
A Phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (DS-8201a), an anti-HER2-antibody drug conjugate, versus ado-trastuzumab emtansine (T-DM1) for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane (DESTINY-Breast03)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 34
- 主要终点
- The primary efficacy endpoint is PFS as determined by blinded independent central review (BICR).
研究概览
简要总结
To compare the progression-free survival (PFS) benefit of trastuzumab deruxtecan to T-DM1 for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adults ≥18 years old. (Please follow local regulatory requirements if the legal age of consent for study participation is >18 y old.) • Pathologically documented breast cancer that: - is unresectable or metastatic - has confirmed HER2 positive expression as determined according to American Society of Clinical Oncology – College of American Pathologists guidelines evaluated at a central laboratory. - was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 mo after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane. • Documented radiologic progression (during or after most recent treatment or within 6 mo after completing adjuvant therapy). • Subjects must be HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. • Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 mo after the last dose of trastuzumab deruxtecan and 7 mo after the last dose of T-DM
- •Male subjects must agree to inform all potential female partners that they are participating in a clinical trial of a drug that may cause birth defects. Male subjects must also agree to either avoid intercourse or that they and/or any female partners of reproductive / childbearing potential will use a highly effective form of contraception during and upon completion of the study and for at least 4.5 mo after the last dose of trastuzumab deruxtecan or 4 mo after the last dose of T-DM
- •Adequate renal function, defined as: - Creatinine clearance ≥ 30 mL/min, as calculated using the Cockcroft-Gault equation • Adequate hepatic function, defined as: - Total bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or < 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline and - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤5 × ULN.
排除标准
- •Prior treatment with an anti-HER2 ADC (such as T-DM1) in the metastatic setting. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 mo of end of adjuvant therapy. • Uncontrolled or significant cardiovascular disease, including any of the following: - History of myocardial infarction within 6 mo before randomization - History of symptomatic congestive heart failure (New York Heart Association Class II to IV) - Troponin levels consistent with myocardial infarction as defined according to the manufacturer within 28 d prior to randomization - Corrected QT interval prolongation to > 470 ms (females) or > 450 ms (male) based on average of Screening triplicate 12 lead electrocardiogram (ECG) - Left ventricular ejection fraction (LVEF) < 50% within 28 d prior to randomization • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. • Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. - Subjects with clinically inactive brain metastases may be included in the study. - Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment. • Prior participation in a study involving an antibody drug conjugate (ADC) produced by Daiichi Sankyo.
结局指标
主要结局
The primary efficacy endpoint is PFS as determined by blinded independent central review (BICR).
The primary efficacy endpoint is PFS as determined by blinded independent central review (BICR).
次要结局
- The key secondary efficacy endpoint is OS.
研究者
Clinical Trial Office
Scientific
Daiichi Sankyo Inc.
研究点 (34)
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