Destiny-breast01 nct03248492
WebFeb 2, 2024 · (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast01 ClinicalTrials.gov number, NCT03248492.) Approximately 15 to 20% of metastatic breast cancers are characterized by overexpression or amplification of human epidermal growth factor receptor 2 (HER2). 1–3 The recommended first-line therapy for HER2-positive … 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 …
Destiny-breast01 nct03248492
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Web转移性乳腺癌 试验背景. ds8201的疗效在destiny-breast01（nct03248492）研究中进行了评估，这是一项多中心、单臂的试验，纳入了184 ... 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 …
WebNov 8, 2024 · In the phase 2 DESTINY-Breast01 trial (NCT03248492), investigators reported a median progression-free survival (PFS) of 16.4 months among 184 heavily pretreated patients. Responses were observed in 112 patients (60.9%); the disease control rate was 97.3%. 2 WebSep 18, 2024 · This is the first report of DESTINY-Breast03 (NCT03529110), a multicenter, open-label, randomized phase 3 study comparing the efficacy and safety of T-DXd vs T-DM1 in pts with HER2+ mBC previously treated with trastuzumab and taxane. This is the first reported randomized study of T-DXd in BC.
WebMay 24, 2024 · Finally, the DESTINY-Breast04 trial (NCT03734029) is investigating trastuzumab deruxtecan versus chemotherapy in patients with HER2-low expressing breast cancer that has spread or cannot be ... WebFeb 22, 2024 · A pooled safety analysis was based on 234 patients treated with at least one dose of Enhertu in DESTINY-Breast01 and in other studies, with a median duration of treatment of 9.8 months. The therapy was generally well-tolerated, with 33 treatment discontinuations (17.9% of patients) due to treatment-emergent side effects (adverse …
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.
WebDec 23, 2024 · Efficacy was investigated in DESTINY-Breast01 (NCT03248492), a multicentre, single-arm trial enrolling 184 female patients with HER2-positive, unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies. Patients received fam-trastuzumab deruxtecan-nxki 5.4 mg/kg by intravenous infusion … orca hundred rabbitsWebDec 30, 2024 · In an updated analysis of the phase 2 DESTINY-Breast01 study, women with HER2-positive metastatic breast cancer taking antibody-drug conjugate trastuzumab deruxtecan continued to demonstrate favorable efficacy data, durable responses, overall survival rates, and a tolerable safety profile. Physician’s Weekly interviews lead study … ips exam subjectsWebAug 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 ... orca home inspectionWeb在 DESTINY-Breast01和DS8201-A-J101研究(NCT02564900)中，对234名接受了至少一剂曲妥珠单抗重组冻干粉注射剂 5.4mg/kg的不可切除或转移性HER2阳性乳腺癌患者的汇总分析中评估了安全性。曲妥珠单抗重组冻干粉注射剂i最常见的不良反应(频率≥20%)为恶心、疲劳、呕吐、脱发 ... ips facilities ltdWebNCT03248492 Other Study ID Numbers: DS8201-A-U201 2016-004986-18 ( EudraCT Number ) JapicCTI-173693(en) ( Registry Identifier: JapicCTI ) DESTINY-Breast01 ( Other Identifier: Daiichi Sankyo and AstraZeneca ) First Submitted: August 10, 2024: First Posted: August 14, 2024: Results First Submitted: January 17, 2024: Results First Posted: … ips fabricationWebJul 14, 2024 · The landmark phase 2 DESTINY-Breast01 trial (NCT03248492), showed that T-DXd had an objective response rate (ORR) of 61.4% and median progression-free survival (mPFS) of 19.4 months in patients with previously treated HER2+ advanced or metastatic breast cancer [2,3]. The trial allowed enrollment of patients with stable brain metastases, … orca house york adressWebMay 28, 2024 · On the basis of findings of the phase 2 DESTINY-Breast01 trial (NCT03248492), T-DXd was approved for the treatment of adult pts with HER2+ unresectable or mBC who have received ≥2 prior anti-HER2–based regimens (US and Europe) or had prior chemotherapy and are refractory to or intolerant of standard … ips exhibition