EUCTR2018-000221-31-CZ进行中（未招募）1 期
A Phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (DS-8201a), an anti-HER2-antibody drug conjugate, versus treatment of investigator’s choice for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with T-DM1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 608
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 T DM1.
- •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 4.5 mo after the last dose of trastuzumab deruxtecan, 6 mo after the last dose of lapatinib/capecitabine, or 7 mo after the last dose of trastuzumab/capecitabine. 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 he and/or any female partner 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, 3 mo after the last dose of lapatinib/capecitabine, or 7 mo after the last dose of trastuzumab/capecitabine.
- •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
- •- Aspartate transaminase/alanine transaminase = 5 × ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 342
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 258
排除标准
- •Ineligible for the comparator arm treatment for reasons including but not limited to the following:
- •- Prior treatment with capecitabine.
- •- History of any contraindication included in the approved local label for capecitabine or for both trastuzumab and lapatinib;
- •- Concurrent treatment with any medication prohibited in the applicable approved local label for capecitabine or for both trastuzumab and lapatinib.
- •Prior participation in an antibody drug conjugate study sponsored by Daiichi Sankyo.
- •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 or 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.
研究者
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