Each participant is expected to receive approximately 14 months of trastuzumab deruxtecan treatment. Trastuzumab emtansine is a treatment option for patients who have not already received it. N Engl J Med. This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. Trastuzumab also stops HER2 from stimulating the growth of cancer cells. trastuzumab deruxtecan, methotrexate. Mechanism of action of trastuzumab deruxtecan (T-DXd). Trastuzumab deruxtecan (T-DXd) is a HER2-directed antibody-drug conjugate that was approved in the US in December 2019 for the treatment of patients with HER2-positive metastatic or unresectable BC who have received 2 or more prior anti-HER2based regimens in the metastatic setting. A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06) Actual Study Start Date : August 20, 2021: Estimated Primary Completion Date : June 29, 2023 Breast cancer is the most commonly diagnosed and deadliest cancer among women worldwide. Background: Methods: We conducted a phase 3, multicenter, open-label, randomized trial to compare the efficacy and safety of trastuzumab deruxtecan (a HER2 antibody-drug conjugate) with those of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. This study is also looking to see how the treatment and the cancer affects patients' quality of life. It may be used with other therapies to treat HER2 positive breast cancer. . Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. Has no prior treatment with trophoblast cell surface antigen 2 (TROP2)-targeted therapy. The ESMO Congress is the most influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. About a quarter of breast cancers overexpress HER2. Trastuzumab Plus Pertuzumab. ICH GCP. Each participant is expected to receive approximately 14 months of trastuzumab deruxtecan treatment. 6-8 hr infusion, 24 hr infusion, or per protocol. DOP1 recommends accelerated approval based on the currently available data. Layout table for additonal information; Last accesses on June 2, 2022. Layout table for additonal information; Part 2 is a dose expansion to examine the safety and efficacy of DS-8201a and it is consist of multiple cohorts: in subjects with trastuzumab emtansine (T-DM1)-treated HER2 overexpressing breast cancer (Part 2a); trastuzumab-treated HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Part 2b); HER2 low expressing breast cancer (Part Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions; A healthcare provider will give you this injection. Arm 1: Trastuzumab Deruxtecan Arm 2: Standard of Care treatment (platinum, pemetrexed and pembrolizumab) Masking: None (Open Label) Study Protocol Statistical Analysis Plan (SAP) Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) Actual Study Start Date : May 21, 2021 Trastuzumab emtansine is a treatment option for patients who have not already received it. This randomized, two-arm, phase 2, multicenter study will evaluate the safety and efficacy of 5.4 mg/kg and 6.4 mg/kg trastuzumab deruxtecan administered every 3 weeks (Q3W) in participants with HER2-mutated metastatic NSCLC. Fam-trastuzumab deruxtecan is given as an infusion into a vein. Breast cancer is the most commonly diagnosed and deadliest cancer among women worldwide. 714-X (PDQ): Integrative, alternative, and complementary therapies - Health Professional Information [NCI] Trastuzumab is a monoclonal antibody that blocks the effects of the growth factor protein HER2, which sends growth signals to breast cancer cells. Breast cancer is the most commonly diagnosed and deadliest cancer among women worldwide. This study is also looking to see how the treatment and the cancer affects patients' quality of life. 4 mg/kg trastuzumab deruxtecan were administered intravenously to patients once every 3 weeks until withdrawal of consent, unacceptable toxicity, or progressive disease. As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. Has no prior treatment with antibody drug conjugate with deruxtecan (including trastuzumab deruxtecan [T-DXd; DS-8201a] and patritumab deruxtecan [HER3-DXd; U31402]). Trastuzumab deruxtecan is given into a vein (intravenously). Part 2 is a dose expansion to examine the safety and efficacy of DS-8201a and it is consist of multiple cohorts: in subjects with trastuzumab emtansine (T-DM1)-treated HER2 overexpressing breast cancer (Part 2a); trastuzumab-treated HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Part 2b); HER2 low expressing breast cancer (Part Trastuzumab deruxtecan is an antibodydrug conjugate with high extracranial activity in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. MA11.03 - Trastuzumab Deruxtecan in HER2-Mutated Metastatic Non-Small Cell Lung Cancer (NSCLC): Interim Results of DESTINY-Lung01 MA11.10 - Lung Master Protocol (Lung-MAP) Next Generation Sequencing Analysis of Advanced Squamous Cell Cancers (SWOG S1400) Third-line or higher treatment. Antibody drug conjugates (Ado-trastuzumab emtansine [Kadcyla], Fam-trastuzumab deruxtecan [Enhertu], Sacituzumab govitecan [Trodelvy]) Although drug combinations are often used to treat early breast cancer, advanced breast cancer often is treated with single chemo drugs. Has no prior treatment with trophoblast cell surface antigen 2 (TROP2)-targeted therapy. Initial results from the TROPION-Lung02 Phase Ib trial showed that datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy demonstrated promising clinical activity and a tolerable safety profile in patients with previously untreated or pretreated, advanced or metastatic non-small cell lung cancer (NSCLC) without Future Oncol. This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. It becomes active once the trastuzumab component has attached to HER2 and enters the cancer cell. Use Caution/Monitor. The DESTINY-Breast03 study, a randomized, phase III trial pitting the antibody-drug conjugates trastuzumab emtansine and trastuzumab deruxtecan against each other in HER2+ metastatic breast cancer, found remarkable improvements in efficacy and safety for the latter, newer therapy. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. Arm 1: Trastuzumab Deruxtecan Arm 2: Standard of Care treatment (platinum, pemetrexed and pembrolizumab) Masking: None (Open Label) Study Protocol Statistical Analysis Plan (SAP) Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. The ESMO Congress is the most influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. Has prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan). Trastuzumab is a monoclonal antibody that blocks the effects of the growth factor protein HER2, which sends growth signals to breast cancer cells. Treatment with trastuzumab deruxtecan (Enhertu) achieved a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status when compared with physicians choice of chemotherapy, Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (updated) 14/10/2022: Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes (updated) 14/10/2022 The clinical benefit rate in the ITT population was 86.7% and 92.9% in the per-protocol population. Arm A - trastuzumab deruxtecan with pertuzumab-matching placebo Arm B - trastuzumab deruxtecan with pertuzumab Arm C - standard of care (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) Has protocol-defined adequate organ and bone marrow function; ECOG performance status 0 or 1; Key Exclusion Criteria: The antiHER2 antibody binds to HER2 on tumor cells, which leads to ADC internalization. QUICK TAKE Trastuzumab Deruxtecan for Breast Cancer 02:05. Trastuzumab deruxtecan is an antibodydrug conjugate with high extracranial activity in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. About a quarter of breast cancers overexpress HER2. Binding of trastuzumab to HER2 inhibits ligand-independent HER2 signalling and prevents the proteolytic cleavage of its extracellular domain, an activation mechanism of HER2. March 23, 2022 The manufacturers of trabectedin (Yondelis), inotuzumab ozogamicin (Besponsa), polatuzumab vedotin (Polivy), enfortumab vedotin (Padcev), trastuzumab deruxtecan (Enhertu), sacituzumab govitecan (Trodelvy), loncastuximab tesirine (Zynlonta), melphalan flufenamide (Pepaxto), belantamab mafodotin (Blenrep), and tisotumab trastuzumab deruxtecan, cisplatin. [3] NCI SEER cancer statistics. Online. This study will examine trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary BC who have residual invasive disease in breast or axillary lymph nodes with higher risk of recurrence, which includes patients who were inoperable at disease presentation or had pathological node-positive status after neoadjuvant Palbociclib, sold under the brand name Ibrance among others, is a medication developed by Pfizer for the treatment of HR-positive and HER2-negative breast cancer.It is a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. trastuzumab deruxtecan, cisplatin. 2022 Jun 5. doi: 10.1056/NEJMoa2203690. Neutropenia Protocol and Algorithms Last Updated: September 2017 BRST - AC + PACLitaxel + trastuzumab Last Updated: March 2022; BRST- DCH Last Updated: June 2022 BRST - trastuzumab deruxtecan (ENHERTU) Last Updated: January 2022; Central Nervous System. Deruxtecan, a toxic substance that kills cells when they attempt to divide and grow. A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06) Actual Study Start Date : August 20, 2021: Estimated Primary Completion Date : June 29, 2023 Trastuzumab Deruxtecan for HER2-Positive Gastric Cancer Approximately 15 to 20% of gastric adenocarcinomas express HER2. This study will examine trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary BC who have residual invasive disease in breast or axillary lymph nodes with higher risk of recurrence, which includes patients who were inoperable at disease presentation or had pathological node-positive status after neoadjuvant Additional Inclusion Criteria for NSCLC participants: The efficacy and safety of trastuzumab deruxtecan (formerly DS-8201), a HER2 antibody-drug conjugate, in patients with HER2 -mutant NSCLC have not been investigated extensively. A combination regimen of the HER2 inhibitors trastuzumab and pertuzumab was studied in a subset analysis of MyPathway, a phase IIa multiple basket study. It may be used with other therapies to treat HER2 positive breast cancer. Trastuzumab deruxtecan is an antibody-drug conjugate that links trastuzumab to a type of chemotherapy. Additional Inclusion Criteria for NSCLC participants: N Engl J Med. This randomized, two-arm, phase 2, multicenter study will evaluate the safety and efficacy of 5.4 mg/kg and 6.4 mg/kg trastuzumab deruxtecan administered every 3 weeks (Q3W) in participants with HER2-mutated metastatic NSCLC. It is licensed for the treatment of breast cancer or gastric or gastroesophageal adenocarcinoma. Epub ahead of print. tretinoin. Study Protocol and Statistical Analysis Plan [PDF] September 25 Lee C, Liu Y, Cathcart J, Bako E, Verma S, Hurvitz SA; DESTINY-Breast03 Trial Investigators. Central Nervous System Regimen Reference Orders. For people with advanced breast cancer that has grown during or after first-line treatment with a HER2-targeted therapy, ASCO recommends trastuzumab deruxtecan as a second-line treatment. Furthermore, based on a recent clinical phase III trial, DESTINY-Breast03, trastuzumab deruxtecan achieved significantly longer progression free survival compared to trastuzumab emtansine (TDM-1 [82,83], or the enrollment in clinical trial protocols, a subject that will be expanded in a later section (Figure 5, Table 2 and Table 3). Trastuzumab Deruxtecan (T-DXd) is an antibodydrug conjugate of trastuzumab and an exatecan derivative (topoisomerase 1 inhibitor). 2022 Mar 24;386(12):1143-1154. doi: 10.1056/NEJMoa2115022. 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