EUCTR2020-005048-46-DK招募中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/MetastaticHER2-Positive Breast Cancer (DESTINY-Breast12) - DESTINY-Breast12
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
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-positive status as determined according to ASCO/CAP guidelines (Wolff et al, 2018) evaluated at a local laboratory
- •2. Participant must have either:
- •(a) No evidence of BM, or
- •(b) Untreated BM on screening contrast brain MRI / CT scan
- •(i)not needing immediate local therapy, or
- •(ii)For participants with untreated CNS lesions:
- •- if lesion = 2 cm, no discussion with study physician is required prior to enrollment
- •- if lesion is > 2.0 cm, discussion with and approval from the study physician is required prior to enrollment, or
- •(c) Previously treated stable or progressing BM
- •(i) Previously treated BM with local therapy may either be radiographically stable for = 4 weeks since completion of treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
- •(ii) Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI/CT scan performed during screening for this study who also have other sites of disease assessable by RECIST 1.1
- •3. Participants with BMs must be neurologically stable and:
- •(a) Be receiving the equivalent of dexamethasone = 3 mg/day mg/day if treatment is required
- •(b) If receiving an anticonvulsant regimen, the regimen must have been stable for = 14 days before first day of dosing
- •(c) Relevant records of any CNS treatment must be available to allow for classification of TLs and NTLs
- •4. Previous breast cancer treatment:
- •(a) Radiologic or objective evidence of disease progression onon or after HER2 targeted therapies.
- •Note: Disease progression within 6 months after adjuvant treatment with HER2 targeted therapies is also acceptable.
- •(b) No more than 2 lines/regimens of therapy in the metastatic setting.
- •Note: A line/regimen of treatment should be counted based on a progression event.
- •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 contrast brain MRI/ CT scan, 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 BMs at a total daily dose of > 3 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 BMs notwithstanding CNS-directed therapy
- •4. Has spinal cord compression
研究者
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