JPRN-jRCT2031210182进行中（未招募）3 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)
Hanai Masaharu0 个研究点目标入组 500 人开始时间: 2021年7月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participant must be >= 18 years at the time of screening.
- •Pathologically documented breast cancer that
- •-Is unresectable/advanced or metastatic, and
- •-Has confirmed HER2-positive status as determined according to ASCO/CAP guidelines
- •Participant must have untreated BM on screening contrast brain MRI/CT scan
- •(i)not needing immediate local therapy, or
- •(ii)For participants with untreated CNS lesions > 2.0 cm, discussion with and approval from the study physician is required prior to enrollment
- •Previously-treated stable or progressing BM
- •(i) 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
- •(ii) Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI/CT scan performed during screening
- •-ECOG performance status 0-1
- •-Previous breast cancer treatment
- •(i)Radiologic or objective evidence of disease progression on trastuzumab, pertuzumab, or T-DM1.
- •(ii)No more than 2 lines/regimens of therapy in the metastatic setting.
- •-Adequate organ and bone marrow function
排除标准
- •-Known or suspected LMD.
- •-Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic CHF (NYHA Class II to IV), unstable angina pectoris, or a recent (< 6 months) cardiovascular event including stroke.
- •-History of (non-infectious) ILD/pneumonitis that required steroids, has current
- •-ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •Lung criteria:
- •(i) Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of study
- •enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc)
- •(ii) Any autoimmune, connective tissue or inflammatory disorders (ie, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for participants who are included in the study.
- •(iii) Prior pneumonectomy
- •-Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 30 days or 5 half-lives, whichever is longer, prior to first dose of study intervention, randomization into a prior T-DXd study regardless of treatment assignment, or concurrent enrollment in another clinical study,
- •unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study.
研究者
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