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

AstraZeneca AB0 个研究点目标入组 350 人开始时间: 2020年12月22日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•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
•c) Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
•-Patient must have adequate tumor sample 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.
•a) No prior lines of therapy for advanced/MBC allowed
•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 315
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•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

发起方