EUCTR2019-004531-22-PL进行中（未招募）1 期
A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with other Anti-cancer Agents in Patients with HER2-positive Metastatic Breast Cancer (DESTINY-Breast07) - DESTINY-Breast07
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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:
- •-Patients must be at least 18 years of age
- •- Pathologically documented breast cancer that:
- •a) Is advanced/unresectable (patients that can be treated with curative
- •intent are not eligible) or metastatic
- •b) HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment.
- •The local HER2 result must be from a tumour sample obtained in the
- •metastatic setting.
- •c) Is documented as hormone receptor-positive (estrogen or
- •progesterone receptor) or negative in the metastatic setting
- •-Patient must have adequate tumor sample from the metastatic setting
- •for biomarker assessment
- •-ECOG Performance Status of 0 or 1
- •a) Disease progression on or after the last systemic therapy prior to
- •starting study treatment
- •b) At least 1 prior treatment line in metastatic setting required.
- •-Part 2 (Modules 0 - 5)
- •a) No prior lines of therapy for advanced/MBC allowed
- •-Part 2 (Module 6 and 7)
- •a) Zero or one prior lines of therapy for advanced/MBC allowed
- •CNS Inclusion
- •-Modules 0 - 5 Patients must have no brain metastases or stable brain
- •metastases.
- •-Module 6 and 7 Patients must have untreated brain metastases not
- •needing local therapy or previously treated brain metastases that have
- •progressed since prior local therapy
- •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 405
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Key Exclusion Criteria:
- •-Uncontrolled or significant cardiovascular disease
- •-Active or prior documented (non-infectious) ILD/pneumonitis that
- •required steroids, or suspected ILD/pneumonitis that cannot be ruled
- •out by imaging at screening
- •-Lung-specific intercurrent clinically significant illnesses
- •-Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- •-Spinal cord compression or a history of leptomeningeal carcinomatosis
- •-Prior treatment with immune checkpoint inhibitors
- •-Prior treatment with an ADC containing a topoisomerase I inhibitor
- •-Prior treatment with tucatinib
- •CNS Exclusion
- •-Modules 0 - 5: Has untreated brain metastasis
- •-Module 6 and 7: Ongoing use of systemic corticosteroids for control of
- •symptoms of brain metastases at a total daily dose of > 2 mg
- •dexamethasone or any brain lesion thought to require immediate local
研究者
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