Destiny-breast01 nct03248492

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August undefined, 2024

WebAug 15, 2024 · Additionally, based on findings from the phase 2 DESTINY-Breast01 trial (NCT03248492), T-DXd was approved by the FDA for those with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2 therapies. 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 …

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

Web2 days ago · The antitumor activity and tolerability of T-DXd was first shown in the phase 2 DESTINY-Breast01 trial (NCT03248492), and was confirmed by findings from the phase 3 DESTINY-Breast03 trial ... tsprint free

Trastuzumab deruxtecan in previously treated HER2 …

WebFeb 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 … 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 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 … ts print crack

T-DXd Combinations in HER2-positive Metastatic Breast Cancer

Trastuzumab deruxtecan in previously treated 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. 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. phish bader fieldWebAug 14, 2024 · Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. phish back on the train

"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 " - Destiny-breast01 nct03248492

Destiny-breast01 nct03248492

Abstract GS1-03: [Fam-] trastuzumab deruxtecan (T-DXd; DS …

WebNCT03248492 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: … 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 …

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WebNov 30, 2024 · Sara Hurvitz, MD:Before we discuss how this data should be implemented in our clinical practice, I'd like to discuss another poster that was presented at ESMO [European Society for Medical Oncology], the updated overall survival results from DESTINY-Breast01 [NCT03248492].Let’s talk about how you are using T-DXd in your … 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 ...

WebMonthly Plenary Series . Abstracts & Presentations 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 …

WebDESTINY-Breast01 (NCT03248492) is an open-label, international, multicenter, phase 2 study of T-DXd in patients with HER2-positive MBC; it supported regulatory approval globally. Data from prior data cutoffs (primary: August 1, 2024; initial update: June 8, 2024) showed that patients receiving T-DXd had durable responses. 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.).

WebT-DXd的抗肿瘤活性和耐受性在2期DESTINY-Breast01试验（NCT03248492）中首次显示，并由3期DESTINY-Breast03试验（NCT03529110）的结果证实。1根据 2 期 DESTINY-Breast3 试验（NCT04）的结果，该药物最近获得 FDA 批准用于 HER03734029 低转移性乳腺癌，表明其在 HER2 的其他历史阴性 ...

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 … tsprint licensingWebJul 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 … tsprint free alternative downloadWebDec 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 … ts printing plusWebFDA approval for Enhertu was based on the results of a multicenter, single-arm, clinical trial, DESTINY-Breast01 (NCT03248492), that enrolled 184 female patients with HER2-positive, unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies in the metastatic setting. Patients were excluded for a history ... phishbait githubWebFeb 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 ... phish bakers dozen box setWebSep 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.” phish baitWebAug 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 ... phish bakers dozen setlists