Destiny-breast01 nct03248492

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August undefined, 2024

WebFeb 15, 2024 · Abstract. BackgroundTrastuzumab deruxtecan (T-DXd, DS-8201) is an antibody-drug conjugate with a HER2 antibody, tetrapeptide-based cleavable linker, and a novel topoisomerase I inhibitor payload. DESTINY-Breast01 (NCT03248492) is an open-label, international, multicenter, phase 2 study of T-DXd in patients with HER2 positive … 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 ...

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WebApr 30, 2024 · The safety of T-DXd was evaluated in a pooled analysis of 234 patients with HER2-positive breast cancer who received at least one dose of T-DXd 5.4 mg/kg in the DESTINY-Breast01 (NCT03248492), and in the phase 1 trial DS8201-A-J101 (NCT02564900) [9,10,22]. The most common adverse events (AE) (i.e., frequency … WebOn 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 treatments (Japan). circular form tool

Efficacy was evaluated in the DESTINY-Breast01 trial - ESMO

WebFeb 15, 2024 · DESTINY-Breast01 (NCT03248492) is an open-label, international, multicenter, phase 2 study of T-DXd in patients with HER2 positive metastatic breast cancer (MBC) and supported regulatory approval ... WebFeb 13, 2024 · In addition to nausea and myelosuppression, interstitial lung disease was observed in a subgroup of patients and requires attention to pulmonary symptoms and careful monitoring. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast01 ClinicalTrials.gov number, NCT03248492.). WebJul 8, 2024 · Krop et al. conducted a phase 2 DESTINY-Breast01 (NCT03248492) study in which 253 patients with metastatic HER2-positive breast cancer previously treated with T-DM1 were included [3]. Median age of the patients was 55 years, 34.2% was Asian, 28.8% North American, and 37% European; 52.7% was HER2+ and 45.1% was HER2- (of … diamond farming royale high 2022

FDA approves fam-trastuzumab deruxtecan-nxki for …

Experts Discuss Third-line Treatment Options for HER2-Positive …

WebDec 10, 2024 · “DESTINY-Breast02 confirms the favorable benefit-risk ratio of trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer.” The 12-month and 24-month PFS rates were 62.3% (95% CI, 57.0%-67.1%) and 42.2% (95% CI, 36.5%-47.8%) of patients who received trastuzumab deruxtecan. 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, … diamond farming 1.19WebFeb 15, 2024 · DESTINY-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 mg/kg) and served to identify … circular form tool holders

"WebJun 10, 2024 · On the basis of findings from J101, T‐DXd was further evaluated in the registrational phase II DESTINY‐Breast01 trial (U201; NCT03248492) in patients with HER2‐positive unresectable or metastatic breast cancer who had previously been treated with T‐DM1. 10 Patients enrolled in this trial were heavily pretreated, having received a … " - Destiny-breast01 nct03248492

Destiny-breast01 nct03248492

A Study of DS-8201a in Metastatic Breast Cancer …

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 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.

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WebMar 30, 2024 · In DESTINY-Breast01 (NCT03248492) and DESTINY-Breast03 (NCT03529110), trastuzumab deruxtecan (T-DXd) demonstrated unprecedented activity in patients (pts) with HER2+ (immunohistochemistry 3 ... WebDec 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 …

WebJul 14, 2024 · Pooling data from August 2015 to June 2024 (61 patients participated in phase 1 studies DS8201-A-J101 [NCT02564900], and DS8201-A-A104 [NCT03383692], and 184 patients were in the phase 2 DESTINY-Breast01 study [NCT03248492]), including this update from ASCO, indicated that ILD occurred in 15.5% of patients with HER2 … Web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 ...

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 …

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 … diamond farming w101WebNCT03248492 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: … circular formworks supplier philippinesWebBackground: 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 … circular formwork singaporeWebDec 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 … diamond farm in minecraftWebSep 18, 2024 · “In comparison trastuzumab deruxtecan had a risk of [10.5%], so 5-fold higher than T-DM1, but lower than that seen inn DESTINY-Breast01 [NCT03248492].” Most importantly, Modi added, no grade 4 or 5 ILD/pneumonitis events were observed, “a major difference from DESTINY-Breast01 and a major relief.” circular for north shore farmsWebDec 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 … circular formwork columnsWebSep 1, 2024 · The DESTINY-Breast01 study is a clinical study in participants with a type of breast cancer called HER2-positive breast cancer. The participants in the study received a treatment called trastuzumab deruxtecan, also known as T-DXd. circular forms fashion