WebBackground: DESTINY-Breast01 (NCT03248492) is a phase II single-arm trial evaluating trastuzumab deruxtecan (T-DXd) in adults with human epidermal growth factor receptor 2-positive (HER2+) unresectable or metastatic breast cancer (u/mBC) who have received two or more prior anti-HER2 therapies. Objectives: Objectives were to explore approaches … WebApr 13, 2024 · DESTINY-Breast01. In an interim analysis of the first immunotherapy combination phase 1b trial of immunotherapy together with trastuzumab deruxtecan, safety results showed nivolumab with trastuzumab deruxtecan was well tolerated in patients with HER2-positive or HER2-low metastatic breast cancer. ... 59% for HER2-positive disease, …
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WebT-DXd has been approved for HER2-positive metastatic breast cancer and for HER2-positive metastatic gastric cancer. The approval in breast cancer was based on results from the DESTINY-Breast01 (U201; NCT03248492) and J101 (NCT02564900) trials. Here, we present dose justification for the approved 5.4 mg/kg every-3-weeks (Q3W) dose based … WebJun 20, 2024 · As you recall, trastuzumab deruxtecan was initially approved based on DESTINY-Breast01 [NCT03248492]. DESTINY-Breast03 was a study that brought it up into an earlier-line setting, so patients that had seen trastuzumab and/or a taxane in the metastatic setting or relapsed within 6 months of neoadjuvant or adjuvant therapy. sigma death stare
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WebDec 11, 2024 · (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast01 ClinicalTrials.gov number, NCT03248492.) ... DESTINY-Breast01 was a single-group study with a median follow-up of only 11 months. Study Design and Patients. In this randomized, double-blind, placebo … WebDESTINY-Breast01 (NCT03248492) is an open-label, international, multicenter, phase 2 registration study of T-DXd in subjects with centrally confirmed HER2-positive metastatic BC. Methods Part 1 of this 2-part study was performed in 2 stages (pharmacokinetics and dose finding; T-DXd 5.4, 6.4, 7.4 WebAug 5, 2024 · In the DESTINY-Breast01 phase II trial (NCT03248492), T-DXd demonstrated high rates of durable responses in heavily pretreated patients with HER2-positive mBC, with a confirmed objective response rate of 62%, median duration of response of 18.2 months, and median progression-free survival of 19.4 months. In addition to efficacy, successful ... the prince \u0026 me 4