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 244 人开始时间: 2024年4月24日最近更新: 2024年7月22日

适应症

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•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, Part 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, 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

•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 therapy

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