EUCTR2020-005048-46-IT进行中（未招募）1 期
An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously-Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12) - DESTINY-Breast12
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Key inclusion Criteria:
- •1. Pathologically documented breast cancer that:
- •(a) Is unresectable/advanced or metastatic, and
- •(b) Has confirmed HER2+ expression
- •2. Participant must have either:
- •(a) No evidence of BM, or
- •(b) Untreated BM not needing immediate local therapy, or
- •- For participants with untreated CNS lesions > 2.0 cm on screening contrast brain MRI, discussion with and approval from the study physician is required prior to enrollment, or
- •(c) Previously treated stable or progressing BM
- •- Previously treated BM with local therapy may either be radiographically stable for >= 4 weeks since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
- •- Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study who also have other sites of disease assessable by RECIST 1.1
- •3. Participants with brain metastases must be neurologically stable and:
- •(a) Be receiving the equivalent of dexamethasone <= 2 mg/day
- •(b) If receiving an anticonvulsant regimen, the regimen must have been stable for >= 14 days
- •(c) Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
- •4. Radiologic or objective evidence of disease progression on trastuzumab, pertuzumab, or T-DM1 (<= 2 lines/regimens of therapy in the metastatic setting)
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Known or suspected LMD
- •2. Prior exposure to tucatinib treatment
- •3. Based on screening brain MRI, participants must not have any of the following:
- •(a) Any untreated brain lesions > 2.0 cm in size
- •(b) Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent).
- •(c) Any brain lesion thought to require immediate local therapy,
- •(d) Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy
- •4. Has spinal cord compression
研究者
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