The purpose of this study is to determine if intranasal (IN) Ketorolac in combination with oral Prochlorperazine and Diphenhydramine is non-inferior to current migraine management which involves use of intravenous (IV) Ketorolac and oral adjuncts Prochlorperazine and diphenhydramine for reducing pain intensity in children with migraine headaches.
The investigators hypothesize that IN ketorolac combined with these oral adjuncts is non-inferior to IV ketorolac and oral adjuncts in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.

开始日期2024-01-01

申办/合作机构

Washington University School of Medicine

[+1]

NCT06182098

/ RecruitingN/AIIT

Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine

The goal of this clinical trial is to compare intravenous (IV) fluids in pediatric patients with migraine. The main questions it aims to answer are:
Does a large amount of fluids (bolus) improve pain
Does a large amount of fluids (bolus) reduce admissions to the hospital for migraine Participants will be asked to report their pain and have vital signs checked every 30 minutes for two hours.
Researchers will compare a large amount of fluids (bolus) to a small amount (half maintenance) to see if there is a difference in pain improvement.

开始日期2023-06-27

申办/合作机构

Dayton Children's Hospital

NCT06310642

/ Completed临床4期IIT

A Prospective Single-Blinded Randomized Field-Based Trial to Evaluate the Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score.

开始日期2021-05-20

申办/合作机构

CHRISTUS Health, Inc.

100 项与乙二磺酸丙氯拉嗪相关的临床结果

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100 项与乙二磺酸丙氯拉嗪相关的转化医学

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100 项与乙二磺酸丙氯拉嗪相关的专利（医药）

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1,601

项与乙二磺酸丙氯拉嗪相关的文献（医药）

2025-03-24·ANGEWANDTE CHEMIE-INTERNATIONAL EDITION

Functionalization of Pyridines at the C4 Position via Metalation and Capture

Article

作者: Hsu, Han‐Hsiang ; Sk, Md Raja ; Thomas, Andy A. ; Chen, Cheng‐Chun ; Kang, Seokmin

Abstract:

The functionalization of pyridines at positions remote to the N‐atom remains an outstanding problem in organic synthesis. The inherent challenges associated with overriding the influence of the embedded N‐atom within pyridines was overcome using n‐butylsodium, which provided an avenue to deprotonate and functionalize the C4‐position over traditionally observed addition products that are formed with organolithium bases. In this work, we show that freshly generated 4‐sodiopyrdines could undergo transition metal free alkylation reactions directly with a variety of primary alkyl halides bearing diverse functional groups. In addition, after transmetalation to zinc chloride a simple and efficient Negishi cross‐coupling protocol was formulated for a variety of aromatic and heteroaromatic halides. The robustness of this protocol was demonstrated through the late‐stage installation of 4‐pyridyl fragments into a variety of complex active pharmaceutical ingredients including loratadine and prochlorperazine. Furthermore, through rapid injection NMR investigations, we are able to directly observe the evolution of anionic intermediates and determined that two distinct mechanistic pathways lead to the observed site selectivity: (1) the C4‐H within 2,6‐disubstituted pyridines could be removed directly and (2) the C4 selectivity of unsubstituted pyridine originates from the intermolecular exchange of metalation sites via a thermodynamic pathway.

2024-11-01·Molecular neurobiology

A Multistep In Silico Approach Identifies Potential Glioblastoma Drug Candidates via Inclusive Molecular Targeting of Glioblastoma Stem Cells

Article

作者: Dogra, Nilambra ; Singh, Parminder ; Kumar, Ashok

Glioblastoma (GBM) is the highest grade of glioma for which no effective therapy is currently available. Despite extensive research in diagnosis and therapy, there has been no significant improvement in GBM outcomes, with a median overall survival continuing at a dismal 15-18 months. In recent times, glioblastoma stem cells (GSCs) have been identified as crucial drivers of treatment resistance and tumor recurrence, and GBM therapies targeting GSCs are expected to improve patient outcomes. We used a multistep in silico screening strategy to identify repurposed candidate drugs against selected therapeutic molecular targets in GBM with potential to concomitantly target GSCs. Common differentially expressed genes (DEGs) were identified through analysis of multiple GBM and GSC datasets from the Gene Expression Omnibus (GEO) and The Cancer Genome Atlas (TCGA). For identification of target genes, we selected the genes with most significant effect on overall patient survival. The relative mRNA and protein expression of the selected genes in TCGA control versus GBM samples was also validated and their cancer dependency scores were assessed. Drugs targeting these genes and their corresponding proteins were identified from LINCS database using Connectivity Map (CMap) portal and by in silico molecular docking against each individual target using FDA-approved drug library from the DrugBank database, respectively. The molecules thus obtained were further evaluated for their ability to cross blood brain barrier (BBB) and their likelihood of resulting in drug resistance by acting as p-glycoprotein (p-Gp) substrates. The growth inhibitory effect of these final shortlisted compounds was examined on a panel of GBM cell lines and compared with temozolomide through the drug sensitivity EC50 values and AUC from the PRISM Repurposing Secondary Screen, and the IC50 values were obtained from GDSC portal. We identified RPA3, PSMA2, PSMC2, BLVRA, and HUS1 as molecular targets in GBM including GSCs with significant impact on patient survival. Our results show GSK-2126458/omipalisib, linifanib, drospirenone, eltrombopag, nilotinib, and PD198306 as candidate drugs which can be further evaluated for their anti-tumor potential against GBM. Through this work, we identified repurposed candidate therapeutics against GBM utilizing a GSC inclusive targeting approach, which demonstrated high in vitro efficacy and can prospectively evade drug resistance. These drugs have the potential to be developed as individual or combination therapy to improve GBM outcomes.

2024-09-23·Journal of Chemical Information and Modeling

Prediction of Inhibitory Activity against the MATE1 Transporter via Combined Fingerprint- and Physics-Based Machine Learning Models

Article

作者: Sasaki, Shunta ; Bender, Andreas ; Iijima, Takeshi ; Kageyama, Michiharu ; Asano, Satoshi ; Handa, Koichi

Renal secretion plays an important role in excretion of drug from the kidney. Two major transporters known to be highly involved in renal secretion are MATE1/2 K and OCT2, the former of which is highly related to drug-drug interactions. Among published in silico models for MATE inhibitors, a previous model obtained a ROC-AUC value of 0.78 using high throughput percentage inhibition data [J. Med. Chem. 2013, 56(3), 781-795] which we aimed to improve upon here using a combined fingerprint and physics-based approach. To this end, we collected 225 publicly available compounds with pIC50 values against MATE1. Subsequently, on the one hand, we performed a physics-based approach using an Alpha-Fold protein structure, from which we obtained MM-GB/SA scores for those compounds. On the other hand, we built Random Forest (RF) and message passing neural network models using extended-connectivity fingerprints with radius 4 (ECFP4) and chemical structures as graphs, respectively, which also included MM-GB/SA scores as input variables. In a five-fold cross-validation with a separate test set, we found that the best predictivity for the hold-out test was observed in the RF model (including ECFP4 and MM-GB/SA data) with an ROC-AUC of 0.833 ± 0.036; while that of the MM-GB/SA regression model was 0.742. However, the MM-GB/SA model did not show a dependency of the performance on the particular chemical space being predicted. Additionally, via structural interaction fingerprint analysis, we identified interacting residues with inhibitor as identical for those with noninhibitors, including substrates, such as Gln49, Trp274, Tyr277, Tyr299, Ile303, and Tyr306. The similar binding modes are consistent with the observed similar IC50 value inhibitor when using different substrates experimentally, and practically, this can release the experimental scientists from bothering of selecting substrates for MATE1. Hence, we were able to build highly predictive classification models for MATE1 inhibitory activity with both ECFP4 and MM-GB/SA score as input features, which is fit-for-purpose for use in the drug discovery process.

项与乙二磺酸丙氯拉嗪相关的新闻（医药）

2025-02-27

·PRNewswire

Neurocrine Biosciences Reports Patient-Reported Outcome Data from KINECT-PRO™ Study for INGREZZA® (valbenazine) Capsules in Tardive Dyskinesia: Significant and Clinically Meaningful Improvements in Functionality and Quality of Life Measures

SAN DIEGO, Feb. 27, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line data from a Phase 4 study, KINECT-PRO™, demonstrating clinically meaningful and sustained effects of INGREZZA® (valbenazine) capsules on the physical, social and emotional impacts experienced by patients living with tardive dyskinesia (TD), irrespective of TD severity or underlying psychiatric condition. KINECT-PRO is the first study to show patient-reported impact of a vesicular monoamine transporter 2 inhibitor, specifically INGREZZA, on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale used to evaluate the physical, social and emotional impact of involuntary movements. These patient-reported outcome measures provide a more complete perspective on a patient's experience of living with TD and the broad range of improvements that occurred following treatment with INGREZZA. The results of KINECT-PRO will be shared at upcoming scientific conferences. "Tardive dyskinesia can significantly impact many aspects of patients' lives, including daily activities, work or school attendance and social interactions," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "The data from the KINECT-PRO trial, which was designed to follow typical clinical practice, show that patients and clinicians observed substantial reduction in the impact and severity of TD, as well as improvement in overall quality of life with use of INGREZZA. Importantly, patients reported significant improvements across measures regardless of their underlying psychiatric conditions or the baseline severity of their TD involuntary movement symptoms." Fifty-nine patients were enrolled in the KINECT-PRO study and received once-daily INGREZZA (40 mg, 60 mg or 80 mg) for up to 24 weeks. Fifty-two patients completed the Week 24 visit. There were comparable numbers of patients across TD severity (mild vs. moderate/severe) and underlying psychiatric condition subgroups (schizophrenia or schizoaffective disorder vs. bipolar disorder or major depression). The primary objective of the KINECT-PRO study was to evaluate changes in patient-reported physical and socio-emotional impacts of TD, changes in a person's work, family, social life and overall sense of health and well-being during INGREZZA treatment. These outcomes were measured at Weeks 4, 8, 16 and 24 by the Tardive Dyskinesia Impact Scale (TDIS), the Sheehan Disability Scale (SDS) and the EQ Visual Analogue Scale (EQ-VAS), respectively. The secondary objective was to evaluate clinician- and patient-reported changes in TD severity as measured by the Abnormal Involuntary Movement Scale (AIMS), the Patient Global Impression of Change–TD (PGI-C) and Clinical Global Impression of Severity–TD (CGI-TD-S). Results showed significant and sustained improvements from baseline in all three patient-reported outcome measures, including patients with either mild or moderate/severe TD, with improvements observed as early as four weeks at the lowest dose (40 mg). AIMS scores also showed sustained reductions in involuntary movements, regardless of TD severity or underlying psychiatric condition. In the study, safety and tolerability of treatment was consistent with the known profile of INGREZZA, with no new concerns identified. About the KINECT-PRO™ Phase 4 Study The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT®-3 and KINECT®-4 studies. About the Tardive Dyskinesia Impact Scale (TDIS) The Tardive Dyskinesia Impact Scale (TDIS) is a novel, psychometrically validated patient-reported outcome measure in TD. It was developed by Neurocrine Biosciences from qualitative studies and Phase 3 trials of INGREZZA for the treatment of TD (KINECT®-3 and KINECT®-4) as a comprehensive measure of impact and burden of TD from a patient's perspective. The TDIS consists of 11 questions evaluating physical and socio-emotional impact. Six domains are assessed: mouth/throat, dexterity, mobility, pain, social and emotional. The TDIS allows people with TD to rate how their symptoms affect daily activities and how their uncontrollable movements make them feel. The questionnaire captures relevant information about the impact of TD to provide a more holistic assessment of the condition. Validation of this scale was published in the Journal of Patient-Reported Outcomes. About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA® SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088. Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit LinkedIn, X and Facebook. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0047 02/2025 SOURCE Neurocrine Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期上市批准临床2期

2024-11-05

·ioncology

SABCS 2024丨乳腺癌领域年终盛典将至，重磅研究汇总！

点击蓝字，关注我们编者按：第47届圣安东尼奥乳腺癌研讨会（SABCS）将于当地时间2024年12月10日至13日在美国得克萨斯州圣安东尼奥举行。日前，官网已公布摘要题目，肿瘤瞭望特将Late-Breaking Oral Presentations、General Session、Rapid Fire、Poster Spotlight Sessions等环节口头报告内容进行整理，敬请关注！ Late-Breaking Oral Presentations 时间：12月10日6:00 – 7:00 pm 地点：Stars at Night 1-2 主持人：Rita Nanda, University of Chicago Medicine, Chicago, Illinois LB1-01: Long-term effects of the omission of immediate surgery in operable breast cancer, or reduction of surgical extent: patient-level meta-analysis of the four randomised trials among 2,514 women. 可手术乳腺癌中省略即刻手术或缩小手术范围的长期影响：基于2514名女性的四项随机试验患者层面的荟萃分析讲者：Robert Hills, University of Oxford, Oxford, United Kingdom LB1-02: MARGOT/TBCRC052: A randomized phase II trial comparing neoadjuvant paclitaxel/margetuximab/pertuzumab (TMP) vs paclitaxel/trastuzumab/pertuzumab (THP) in patients (pts) with stage II-III HER2+ breast cancer. MARGOT/TBCRC052：一项随机II期临床试验，比较II-III期HER2阳性乳腺癌患者中新辅助治疗帕妥珠单抗/马吉妥昔单抗/紫杉醇（TMP）vs帕妥珠单抗/曲妥珠单抗/紫杉醇（THP）的疗效讲者：Adrienne Waks, Dana-Farber Cancer Institute, Boston, Massachusetts LB1-03: Primary results of the randomised Phase III trial comparing first-line ET plus palbociclib vs standard mono-chemotherapy in women with high risk HER2-/HR+ metastatic breast cancer and indication for chemotherapy - PADMA study. PADMA研究：比较高危HR+/HER2-转移性乳腺癌女性患者一线ET联合哌柏西利vs标准单药化疗的随机III期试验的主要结果讲者：Sibylle Loibl, German Cooperative Group, Neu-Isenburg, Germany LB1-04: Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) by pace of disease progression on prior endocrine-based therapy: additional analysis from DESTINY-Breast06. 基于既往内分泌治疗的疾病进展速度，比较德曲妥珠单抗（T-DXd） vs医生选择的化疗（TPC）的疗效与安全性：来自DESTINY-Breast06的额外分析讲者：Aditya Bardia, UCLA David Geffen School of Medicine, Los Angeles, California LB1-05: ROSC (Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER- early breast cancer according to ET-response: final survival results from the WSG ADAPT-HR+/HER2- chemotherapy-trial. 在遗传或临床高危HR+/HER2-早期乳腺癌中，根据ET反应（新）辅助nab-PAC周疗 vs 每2周1次sb-PAC，随后每2周1次EC：WSG ADAPT-HR+/HER2-化疗试验最终生存结果讲者：Sherko Kuemmel, German Medical Institute, Limassol, Germany LB1-06: Primary results of SOLTI VALENTINE: neoadjuvant randomized phase II trial of HER3-DXd alone or in combination with letrozole for high-risk hormone receptor positive (HR+)/HER2-negative (neg) early breast cancer (EBC). SOLTI VALENTINE研究的主要结果：针对高风险HR+/HER2-早期乳腺癌（EBC），比较单独使用HER3-DXd或联合使用来曲唑新辅助治疗的随机II期试验讲者：Mafalda Oliveira, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain LB1-07: Exploratory Biomarker Analysis of the Phase 3 KEYNOTE-522 Study of Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for Early-Stage TNBC. 3期KEYNOTE-522研究生物标志物探索性分析：对早期TNBC患者用帕博利珠单抗或安慰剂联合化疗进行新辅助治疗，随后用帕博利珠单抗或安慰剂进行辅助治疗讲者：Joyce O’Shaughnessy, Baylor-Sammons Cancer Center, Dallas, Texas General Session 1 时间：12月11日9:15 – 11:30 am 地点：Hall 1 GS1-01: Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy and Combined with Abemaciclib, for Patients w/ ER+, HER2- Advanced Breast Cancer (ABC), Pretreated w/ Endocrine Therapy (ET): Results of the Phase 3 EMBER-3 trial. 口服选择性雌激素受体降解剂（SERD）Imlunestrant单药治疗及联合阿贝西利治疗既往接受内分泌治疗（ET）的雌激素受体阳性（ER+）、人表皮生长因子受体2阴性（HER2-）晚期乳腺癌（ABC）患者的疗效：III期EMBER-3研究结果讲者：Komal Jhaveri, Memorial Sloan Kettering Cancer Center, New York, New York GS1-03: Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial. 吡咯替尼或安慰剂联合曲妥珠单抗和多西他赛用于未接受过治疗的HER2阳性转移性乳腺癌（mBC）：III期PHILA试验预设的无进展生存期（PFS）最终分析讲者：徐兵河（中国医学科学院肿瘤医院） GS1-04: HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial. 靶向HER2的抗体-药物偶联物SHR-A1811用于HER2阳性早期乳腺癌的新辅助治疗：一项前瞻性、随机、开放标签的2期试验讲者：李俊杰（复旦大学附属肿瘤医院） GS1-06: PRO B – a superiority randomized controlled trial evaluating the effects of symptom monitoring in metastatic breast cancer patients. PRO B ——一项评估转移性乳腺癌患者症状监测效果的优效性随机对照试验讲者：Maria Margarete Karsten, Charité-Universitätsmedizin, Berlin GS1-08: Association between risk-reducing surgeries and survival in young BRCA carriers with breast cancer: results from an international cohort study. 年轻乳腺癌患者中BRCA携带者接受降低风险性手术与生存期之间的关联：一项国际队列研究结果讲者：Matteo Lambertini, University of Genova, Genova, Italy GS1-09: OlympiA- Phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1/BRCA2 pathogenic variants & high risk HER2-negative primary breast cancer; longer term follow. OlympiA长期随访——一项针对携带胚系BRCA1/BRCA2致病性变异且高危HER2阴性原发性乳腺癌患者，在（新）辅助化疗后使用辅助奥拉帕利（olaparib）的III期、多中心、随机、安慰剂对照试验讲者：Judy Garber, Dana-Farber Cancer Institute, Boston, Massachusetts Rapid Fire 1 时间：12月11日12:00 – 12:50 pm 地点：Stars at Night 1-2 主持人：Moderator: Shom Goel, University of Melbourne Peter MacCallum Cancer Centre RF1-01: Effect of a weight loss intervention (WLI) on metabolic and inflammatory biomarkers in women with obesity and breast cancer: Results from the Breast Cancer Weight Loss (BWEL) Trial (Alliance). 减重干预（WLI）对肥胖合并乳腺癌女性的代谢和炎症生物标志物的影响：乳腺癌减重（BWEL）试验（Alliance）的结果讲者：Jennifer Ligibel, Dana-Farber Cancer Institute, Boston, Massachusetts RF1-02: Palbociclib plus letrozole versus weekly paclitaxel, both in combination w/ trastuzumab plus pertuzumab, as neoadjuvant treatment for patients w/ HR+/HER2+ early breast cancer: primary results from the randomized phase II TOUCH trial (IBCSG 55-17). 哌柏西利联合来曲唑对比周疗紫杉醇，两者均与曲妥珠单抗和帕妥珠单抗联用，作为HR+/HER2+早期乳腺癌患者的新辅助治疗：来自II期TOUCH随机试验（IBCSG 55-17）的主要结果讲者：Luca Malorni, USL Toscana Centro, Hospital of Prato, Prato, Italy RF1-03: Three-year event-free survival (EFS) of the multicenter phase II TRAIN-3 study evaluating image-guided optimization of neoadjuvant chemotherapy duration in stage II and III HER2-positive breast cancer (BOOG 2018-01). 多中心II期TRAIN-3研究评估了II期和III期HER2阳性乳腺癌（BOOG 2018-01）中基于影像引导的新辅助化疗持续时间优化的三年无事件生存率（EFS）讲者：Fleur Louis, Antoni van Leeuwenhoekziekenhuis, Amsterdam, Netherlands RF1-04: Long-Term Follow-up and updated analysis from S0221, Comparing Alternative Dose-Schedules of Adjuvant Anthracycline/Taxane Therapy in High-Risk Early Breast Cancer. S0221研究长期随访与更新分析：比较蒽环类/紫杉类辅助治疗高危早期乳腺癌的替代剂量方案讲者：Azka Ali, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois RF1-05: DNA methylation patterns are similar in benign tissue from ipsilateral and contralateral breast while different from matched breast cancer, and healthy controls. 同侧与对侧乳房的良性组织中的DNA甲基化模式相似，但与配对的乳腺癌组织和健康对照组存在差异讲者：Saya Dennis, Northwestern University Feinberg School of Medicine, Chicago, Illinois RF1-06: Association of polygenic-based breast cancer risk prediction with patient management. 基于多基因的乳腺癌风险预测与患者管理的相关性讲者：Katie Johansen Taber, Myriad Genetics, San Francisco, California RF1-07: Multifactor analysis for pathologic complete response (pCR) in a chemotherapy-free regimen of durvalumab, trastuzumab, and pertuzumab (DTP Trial) in HER2-enriched early breast cancer. 在HER2过表达的早期乳腺癌中，不含化疗的度伐利尤单抗、曲妥珠单抗和帕妥珠单抗方案（DTP研究）的病理完全缓解（pCR）的多因素分析讲者：Bojana Stefanovska, UT Health Science Center, San Antonio, Texas General Session 2 时间：12月12日9:00–11:45 am 地点：Hall 1 GS2-01: Exclusive endocrine therapy or radiation therapy in women aged 70+ years with luminal-like early breast cancer (EUROPA): preplanned interim analysis of a randomized phase 3 trial. 随机3期EUROPA研究预先计划的期中分析：70岁以上luminal型早期乳腺癌女性患者单纯内分泌治疗或放疗的疗效讲者：Icro Meattini, University of Florence, Florence, Italy GS2-02: Impact of Tamoxifen Only after Breast Conservation Surgery for "Good Risk" Duct Carcinoma in Situ: Results from the NRG Oncology/RTOG 9804 and ECOG-ACRIN E5194 Trial “低风险”原位导管癌保乳术后仅采用他莫昔芬治疗的影响：NRG Oncology/RTOG 9804和ECOG-ACRIN E5194试验的结果讲者：Jean Wright, University of North Carolina School of Medicine, Chapel Hill, North Carolina GS2-03: Does postmastectomy radiotherapy in 'intermediate-risk' breast cancer impact overall survival? 10-year results of the BIG 2-04 MRC SUPREMO randomised trial: on behalf of the SUPREMO trial investigators. “中危”乳腺癌患者术后放疗是否影响总生存期？BIG 2-04 MRC SUPREMO随机试验10年结果：代表SUPREMO试验研究者讲者：Ian Kunkler, Edinburgh Cancer Centre, University of Edinburgh, Edinburgh, Scotland GS2-05: Early Oncologic Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS: the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25). 低危导管原位癌（DCIS）患者主动监测或手术（±放疗）后的早期肿瘤学结局：比较手术与监测伴或不伴内分泌治疗（COMET）研究（AFT-25）讲者：Eun-Sil Hwang, Duke University School of Medicine, Durham, North Carolina GS2-06: Patient Reported Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS in the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25). 低危导管原位癌（DCIS）患者主动监测或手术（±放疗）后的患者报告结局：比较手术与监测伴或不伴内分泌治疗（COMET）研究（AFT-25）讲者：Ann Partridge, Dana-Farber Cancer Institute, Boston, Massachusetts GS2-07: No axillary surgery versus axillary sentinel lymph node biopsy in patients with early invasive breast cancer and breast-conserving surgery: Final primary results of the Intergroup-Sentinel-Mamma (INSEMA) trial. 早期浸润性乳腺癌患者不接受腋窝手术vs接受保乳手术的腋窝前哨淋巴结活检比较：INSEMA（intergroup sentinel - mamma）试验的最终主要结果讲者：Toralf Reimer, Universitätsmedizin Rostock, Rostock, Germany GS2-09: Overweight, obesity and prognosis in 206,904 women in the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) database. 早期乳腺癌试验协作组（Early Breast Cancer trials’Collaborative Group，EBCTCG）数据库中206904名女性的超重、肥胖和预后情况讲者：Hongchao Pan, University of Oxford, Oxford, United Kingdom GS2-10: A long-term image-derived AI risk model for primary prevention of breast cancer. 用于乳腺癌一级预防的基于长期图像衍生的AI风险模型讲者：Mikael Eriksson, Karolinska Institutet, Solna, Sweden GS2-11: APOBEC3 mutagenesis induces resistance-promoting genomic alterations in breast cancer. APOBEC3突变诱导乳腺癌中促进耐药的基因组改变讲者：Avantika Gupta, Memorial Sloan Kettering Cancer Center, New York, New York Rapid Fire 2 时间：12月12日12:00 – 12:50 pm 地点：Hall 1 主持人：Carlos Arteaga, UT Southwestern, Dallas, Texas RF2-01: Factors Influencing Additional Nodal Disease and Pathologic Nodal Upstaging with Axillary Dissection in Patients with Residual Node-Positive Breast Cancer After Neoadjuvant Chemotherapy Enrolled on Alliance A011202 Clinical Trial. Alliance A011202临床试验纳入的新辅助化疗后残留淋巴结阳性乳腺癌患者中，腋窝清扫术对额外淋巴结病变和病理性淋巴结分期上调的影响因素讲者：Judy Boughey, Mayo Clinic, Rochester, Minnesota RF2-02: Axillary surgery after neoadjuvant systemic therapy (NST) for early-stage breast cancer – Treatment algorithms and prognostic impact of residual micrometastases in five neoadjuvant studies. 早期乳腺癌新辅助全身治疗（NST）后的腋窝手术——5项新辅助治疗研究中残留微转移的治疗路径和预后影响讲者：Johannes Holtschmidt, VP Medicine & Research GBG Forschungs GmbH RF2-03: Diagnostic performance of axillary ultrasound after neoadjuvant chemotherapy in initially node-positive breast cancer patients – results from the prospective AXSANA registry trial (NCT04373655). 初诊淋巴结阳性乳腺癌患者新辅助化疗后行腋窝超声的诊断效能——来自前瞻性AXSANA注册试验（NCT04373655）的结果讲者：Steffi Hartmann, University of Rostock, Rostock, Germany RF2-04: Ultrahypofractionated versus conventional fractionated sequential boost after whole-breast radiation therapy in breast cancer patients. One-year cosmetic outcomes of a randomized, controlled, phase 3 trial (ULTIMO). 乳腺癌患者全乳放疗后超大分割vs常规分割序贯加量疗效对比：一项随机、对照、3期试验（ULTIMO）1年美容效果讲者：Melanie Machiels, Universiteit Antwerpen, Antwerp, Belgium RF2-05: Validation of the association between TILs, ER status and benefit of radiotherapy in node positive, breast cancer patients: a DBCG study. DBCG研究：验证TILs、ER状态与淋巴结阳性乳腺癌患者放疗获益之间的关系讲者：Demet Özcan, Aarhus University Hospital, Aarhus, Denmark RF2-06: A Nationwide Double-Blind Phase III RCT Comparing Olanzapine and Prochlorperazine for Refractory Chemotherapy-Induced Nausea in NCORP Community Practices. 一项全国性、双盲、III期、随机对照试验（RCT），比较NCORP社区实践中奥氮平和丙氯拉嗪治疗化疗导致的难治性恶心讲者：Luke Peppone, University of Rochester Medical Center, Rochester, New York General Session 3 时间：12月13日9:00–11:45 am 地点：Hall 1 GS3-01: Circulating tumor DNA surveillance in ZEST, a randomized, phase 3, double-blind study of niraparib or placebo in patients w/ triple-negative breast cancer or HER2+ BRCA-mutated breast cancer with molecular residual disease after definitive therapy. ZEST是一项随机、3期、双盲研究，在尼拉帕利或安慰剂进行根治性治疗后有分子残留病变的三阴性乳腺癌或HER2+ BRCA突变乳腺癌患者中对循环肿瘤DNA进行监测。讲者：Nicholas Turner, Ralph Lauren Centre for Breast Cancer Research, London, United Kingdom GS3-03: Impact of Anthracyclines in High Genomic Risk Node-Negative HR+/HER2- Breast Cancer. 蒽环类药物对高基因组风险淋巴结阴性HR+/HER2-乳腺癌的影响讲者：Nan Chen, University of Chicago Medicine, Chicago, Illinois GS3-04: (Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER2- early breast cancer according to ET-response: final survival results from the WSG ADAPT-HR+/HER2- chemotherapy-trial. 在遗传或临床高危HR+/HER2-早期乳腺癌中，根据ET反应（新）辅助nab-PAC周疗 vs 每2周1次sb-PAC，随后每2周1次EC：WSG ADAPT-HR+/HER2-化疗试验最终生存结果讲者：Sherko Kuemmel, German Medical Institute, Berlin, Germany GS3-05: NSABP B-59/GBG-96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy with atezolizumab or placebo followed by adjuvant atezolizumab or placebo in patients with Stage II and III triple-negative breast cancer. NSABP B-59/GBG-96-GeparDouze：一项针对II期和III期三阴性乳腺癌患者的随机双盲III期临床试验，比较新辅助化疗联合阿替利珠单抗或安慰剂，随后辅助使用阿替利珠单抗或安慰剂的效果讲者：Charles Geyer, University of Pittsburgh, Pittsburgh, Pennsylvania GS3-06: Neoadjuvant camrelizumab plus chemotherapy (chemo) for early or locally advanced triple-negative breast cancer (TNBC): a randomized, double-blind, phase 3 trial. 卡瑞利珠单抗联合化疗（chemo）新辅助治疗早期或局部晚期三阴性乳腺癌（TNBC）：一项随机、双盲、3期试验讲者：邵志敏（复旦大学附属肿瘤医院） GS3-08: In situ detection of individual classical MHC-I gene products in breast cancer identifies gene- and subtype-specific biased antigen presentation loss. 在乳腺癌中原位检测单个经典MHC-I基因产物，可识别出基因和亚型特异性的特异性抗原呈递缺失讲者：Paula Gonzalez-Ericsson, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee GS3-09: Multimodal integration of real world clinical and genomic data for the prediction of CDK4/6 inhibitors outcomes in patients with HR+/HER2- metastatic breast cancer. 真实世界临床和基因组数据的多模态整合用于预测CDK4/6抑制剂在HR+/HER2-转移性乳腺癌患者中的结局讲者：Enrico Moiso, Memorial Sloan Kettering Cancer Center, New York, New York GS3-10: Paired DNA and RNA analysis of CALGB 40603 (Alliance) reveals insights into the molecular and prognostic landscape of stage II-III triple-negative breast cancer. 配对的DNA和RNA分析CALGB 40603（Alliance）揭示了II-III期三阴性乳腺癌的分子和预后特征讲者：Brooke Felsheim, UNC School of Medicine, Chapel Hill, North Carolina Rapid Fire 3 时间：12月13日12:00 – 12:50 pm 地点：Hall 1 主持人：Peter Fasching, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN, Germany RF3-01: TBCRC 056: A phase II study of neoadjuvant niraparib with dostarlimab for patients with BRCA- or PALB2-mutated breast cancer: Results from the ER+/HER2- cohort. TBCRC 056研究ER+/HER2-队列的结果：一项尼拉帕利联合dostarlimab新辅助治疗BRCA突变或PALB2突变乳腺癌患者的II期研究讲者：Erica Mayer, Dana-Farber Cancer Institute, Boston, Massachusetts RF3-02: Efficacy of adjuvant avelumab by PD-L1, tumor infiltrating lymphocytes and residual cancer burden in high-risk triple negative breast cancer: secondary and exploratory endpoints of the phase III A-BRAVE trial. 基于PD-L1、肿瘤浸润淋巴细胞和残余肿瘤负荷对高危三阴性乳腺癌进行阿维鲁单抗辅助治疗的疗效：III期A-BRAVE研究的次要和探索性终点讲者：Maria Vittoria Dieci, University of Padua, Padua, Italy RF3-03: Nivolumab + Ipilimumab (NIVO+IPI) compared to capecitabine for triple-negative breast cancer patients with residual disease after neoadjuvant chemotherapy – Final results of BreastImmune-03, a multicenter randomized open-label phase II trial. 纳武利尤单抗+伊匹木单抗（NIVO+IPI）与卡培他滨在新辅助化疗后有残留病变的三阴性乳腺癌患者中的疗效比较——多中心随机开放标签II期试验BreastImmune-03的最终结果讲者：Olivier Trédan, Centre Lèon Bèrard, Lyon, France RF3-04: NRG-BR004: A Randomized, Double-blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-line HER2-positive Metastatic Breast Cancer. NRG-BR004：紫杉烷/曲妥珠单抗/帕妥珠单抗联合阿替利珠单抗或安慰剂一线治疗HER2阳性转移性乳腺癌的随机、双盲、III期试验讲者：Vicente Valero, MD Anderson Cancer Center, Houston, Texas RF3-05: A Phase 2 Study of Neoadjuvant HER2-targeted Therapy +/- Immunotherapy with Pembrolizumab (neoHIP). 新辅助HER2靶向治疗±帕博利珠单抗免疫治疗的2期研究（neoHIP）讲者：Heather McArthur, UT Southwestern Medical Center, Dallas, Texas RF3-06: Mepitel Film for the Reduction of Radiation Dermatitis in Post-mastectomy Radiation Therapy: Results from Alliance A221803: A Multicenter Phase III Randomized Clinical Trial Mepitel贴膜在减少乳腺癌术后放疗所致放射性皮炎中的应用：Alliance A221803多中心III期随机临床试验结果讲者：Kimberly Corbin, Mayo Clinic, Rochester, Minnesota RF3-07: ROSCO:Response to Optimal Selection of neoadjuvant Chemotherapy in Operable breast cancer: A randomised phase III, stratified biomarker trial of neoadjuvant 5-Fluorouracil, Epirubicin & Cyclophosphamide vs Docetaxel & Cyclophosphamide chemotherapy. ROSCO研究：随机III期、分层生物标志物试验，比较新辅助5-氟尿嘧啶、表柔比星与环磷酰胺vs多西他赛和环磷酰胺化疗方案，评估可手术乳腺癌新辅助化疗最优选择反应。讲者：Daniel Rea, University of Birmingham, Birmingham, United Kingdom Poster Spotlight Sessions ▌Concurrent Poster Spotlight Sessions 1, 3-5, 7 Session 1: New Insights into Immune Biomarkers（免疫生物标志物的新见解）时间：12月11日7:00 – 8:30 am 地点：Room 221ABC 主持人：David Rimm, Yale University Session 3: Highlights on Novel Therapeutics（新型治疗亮点）时间：12月11日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Sara Tolaney, Dana-Farber Cancer Institute Session 4: Prediction of Chemotherapy Response（化疗疗效预测）时间：12月11日7:00 – 8:30 am 地点：Stars at Night 3-4 主持人：Sherene Loi, Peter Macallum Cancer Centre Session 5: The Heart of the Matter - Improving Adverse Effects（核心问题-改善不良反应）时间：12月11日7:00 – 8:30 am 地点：Hemisfair Ballroom 3 主持人：Anne Blaes, Masonic Cancer Center University of Minnesota Session 7: Targeting the ER and PI3K pathway: Novel drugs and combinations（靶向ER和PI3K通路：新型药物和组合）时间：12月11日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：Shom Goel, Peter MacCallum Cancer Centre ▌Concurrent Poster Spotlight Sessions 2, 6, 8, 9 and 15 Session 2: Personalizing CDK 4/6 inhibitor therapy for patients with Metastatic Breast Cancer: Survival, QOL and biomarkers（转移性乳腺癌患者的个体化CDK 4/6抑制剂治疗：生存期、生活质量和生物标志物）时间：12月12日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：Lisa Carey, Lineberger Comprehensive Cancer Center University of North Carolina Session 6: Locoregional Therapy（局部区域治疗）时间：12月12日7:00 – 8:30 am 地点：Room 221ABC 主持人：Mylin Torres, Winshop Cancer Institute of Emory University Session 8: Novel HER2 Therapeutics（新型HER2治疗）时间：12月12日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Ian Krop, Yale School of Medicine Session 9: ctDNA uses for Minimal Residual Disease testing, tumor evolution, and novel technologies（ctDNA用于微小残留病检测、肿瘤进化和新技术）时间：12月12日7:00 – 8:30 am 地点：Stars at Night 3-4 主持人：Charles Perou, Lineberger Comprehensive Cancer Center University of North Carolina Session 15: Survivorship – Biomarker predictors and other survival-associated factors（生存-生物标志物预测和其他生存相关因素）时间：12月12日7:00 – 8:30 am 地点：Room 221ABC 主持人：Lindsay Peterson, Washington University Siteman Cancer Center, St. Louis, Missouri ▌Concurrent Poster Spotlight Sessions 10-14 Session 10: Addressing Racial Disparities in Breast Cancer Outcomes（探讨乳腺癌结局的种族差异）时间：12月13日7:00 – 8:30 am 地点：Hemisfair Ballroom 3 主持人：Yara Abdou, University of North Carolina School of Medicine Session 11: Imaging to Guide Breast Cancer Treatment – Molecular Imaging and AI（影像学指导乳腺癌治疗——分子影像学和人工智能）时间：12月13日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：David Mankoff, Perelman School of Medicine University of Pennsylvania Session 12: Immunobiology Impact on Therapeutic Efficacy（免疫生物学对治疗效果的影响）时间：12月13日7:00 – 8:30 am 地点：Room 221ABC 主持人：Lajos Pusztai, Yale School of Medicine, New Haven, Connecticut Session 13: Molecular determinants of therapeutic response and resistance - Spotight on CDK 4/6i and ADCs （治疗反应和耐药的分子决定因素——聚焦CDK4/6i和ADCs）时间：12月13日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Aditya Bardia, UCLA David Geffen School of Medicine, Los Angeles, California Session 14: Brain Metastasis（脑转移）时间：12月13日7:00–8:30 am 地点：Stars at Night 3-4 主持人：William Gradishar, Northwestern University Feinberg School of Medicine, Chicago, Illinois （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期抗体药物偶联物

2024-11-04

·neurocrine.gcs-web.com

Neurocrine Biosciences Presents New Data on INGREZZA® (valbenazine) Capsules at Psych Congress 2024: Majority of Long-Term Study Participants Achieved Remission of Tardive Dyskinesia

SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) presented data from the long-term KINECT®-4 study demonstrating tardive dyskinesia remission in nearly 60% of participants at Week 48 with once-daily INGREZZA® (valbenazine) capsules treatment. This research, "Remission of Tardive Dyskinesia in Patients Receiving Long-Term Valbenazine Treatment" (Poster #98), was shared at the 2024 Psych Congress in Boston. "Tardive dyskinesia is persistent and irreversible, and effective treatment over time can have a positive impact for patients who are already living with underlying psychotic and mood disorders," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "Our clinical studies have shown clinically meaningful and sustained improvement in tardive dyskinesia with INGREZZA, and these remission data add to the body of evidence characterizing the robust impact of INGREZZA treatment." This post hoc analysis was conducted using data from 103 participants who reached the final Week 48 visit in the open-label KINECT-4 clinical trial. Remission was defined as having a score of 1 or less (rating of "none" or "minimal") in each body region (items 1-7) on the Abnormal Involuntary Movement Scale (AIMS). Shifts to remission were defined as a maximum item score of 2 ("mild"), 3 ("moderate") or 4 ("severe") at baseline and each item score of 1 or less at Week 48. Treatment with INGREZZA resulted in tardive dyskinesia (TD) symptom remission for the majority of patients at Week 48: 59.2% (61/103) of participants had a score of 1 or less in each AIMS item. 65.0% (13/20) of participants in the 40 mg dose group and 57.8% (48/83) of participants in the 80 mg dose group met this remission threshold. 10% (10/103) of participants had complete resolution, with a total AIMS score of 0. Of the 4 participants with a maximum item score of 2 at baseline, 50.0% (2/4) reached the remission threshold. Of the 56 participants with a maximum item score of 3 at baseline, 64.3% (36/56) reached the remission threshold. Of the 43 participants with a maximum item score of 4 at baseline, 53.5% (23/43) reached the remission threshold. 65.0% (13/20) of participants in the 40 mg dose group and 57.8% (48/83) of participants in the 80 mg dose group met this remission threshold. Additional Neurocrine Biosciences posters presented at Psych Congress 2024 include: Once-Daily Valbenazine for Tardive Dyskinesia or Huntington's Disease Chorea in Patients with Dysphagia or Swallowing Difficulties (Poster #114) A Multi-Year Survey on United States Psychiatry Clinicians: Trends on Managing Patients with Tardive Dyskinesia (Poster #48) Item Response Theory (IRT) Analyses of the Tardive Dyskinesia Impact Scale (TDIS) (Poster #28) Impact of Valbenazine on Physical, Psychological, and Functional Health in Patients with Tardive Dyskinesia: Results of EQ-5D-5L Health State Scores from 16 Weeks of Valbenazine Treatment (Poster #29) Real World Improvement in Quality of Life and Functional Status of Valbenazine-Treated Patients With Tardive Dyskinesia From a 2024 Chart Extraction and Clinician Survey of 164 Patients (Poster #27) Treatment Effect Sizes of Once-Daily Valbenazine for Tardive Dyskinesia and for Chorea Associated with Huntington's Disease: A Post Hoc Analysis of Phase 3 Clinical Trial Data (Poster #44) About the KINECT-4 Phase 3 Study KINECT®-4 is a Phase 3, open-label study, in which 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received 48 weeks of open-label treatment with once-daily INGREZZA (40 mg or 80 mg capsules) followed by a four-week washout. Dosing was initiated at 40 mg/day in all participants, with escalation to 80 mg/day at Week 4 based on effectiveness and tolerability. Dose reduction to 40 mg was allowed in participants who could not tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated. Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, INGREZZA was generally well tolerated. After Week 4, treatment emergent adverse events (TEAEs) that occurred in ≥5% of all participants (combined dose groups) were urinary tract infection (8.5%) and headache (5.2%). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters and laboratory test values were generally small and not clinically significant. About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 800,000 people in the U.S. About Chorea Associated with Huntington's Disease (HD) Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period. Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease. About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA® SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effect of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter) and Facebook. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo Lockup, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; risks that clinical trial activities may not be predictive of real-world results or of results in subsequent clinical trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2024 Neurocrine Biosciences, Inc. All Rights Reserved View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-new-data-on-ingrezza-valbenazine-capsules-at-psych-congress-2024-majority-of-long-term-study-participants-achieved-remission-of-tardive-dyskinesia-302294580.html SOURCE Neurocrine Biosciences, Inc. Neurocrine Biosciences, Inc., Media: Aimee White, 1-858-354-7865, media@neurocrine.com; Investors: Todd Tushla, 1-858-617-7143, ir@neurocrine.com

临床结果临床3期上市批准

100 项与乙二磺酸丙氯拉嗪相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02609	乙二磺酸丙氯拉嗪	N05AB04	DB00433

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
精神分裂症	美国	GlaxoSmithKline, Inc.	1957-04-08

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02389829 (CTgov)	临床4期	急性偏头痛	127	Hydromorphone (Hydromorphone)	壓鹹範築鹹艱鑰夢鹽鬱 = 襯鏇廠蓋遞膚願憲憲構簾窪遞選鏇觸構衊艱艱 (選齋淵壓鬱膚糧壓範膚, 築衊積範範糧構齋艱壓 ~ 築製觸獵選艱醖膚糧獵) 更多	-	2018-06-06
				Prochlorperazine+Diphenhydramine (Prochlorperazine)	壓鹹範築鹹艱鑰夢鹽鬱 = 廠積鑰窪膚顧構淵蓋醖簾窪遞選鏇觸構衊艱艱 (選齋淵壓鬱膚糧壓範膚, 範鹹構淵衊網鏇繭窪積 ~ 鏇壓構鑰顧齋齋構鬱範) 更多
NCT00610428 (CTgov)	临床2期	先兆偏头痛	75	Staccato Placebo (Inhaled Placebo)	鹽衊構鹹夢簾艱餘網選 = 觸糧鏇獵顧構顧繭鬱簾獵築積窪觸網醖壓觸鏇 (獵壓選築繭糧積繭顧選, 簾選製憲觸選繭窪憲築 ~ 網簾艱遞壓鑰顧鏇膚艱) 更多	-	2018-01-25
				Prochlorperazine+Staccato (Inhaled PCZ 5 mg)	鹽衊構鹹夢簾艱餘網選 = 鏇醖構構襯廠範繭鬱鹹獵築積窪觸網醖壓觸鏇 (獵壓選築繭糧積繭顧選, 鬱淵齋夢窪艱蓋蓋願糧 ~ 夢醖蓋鏇製窪夢鏇醖網) 更多
NCT00590317 (CTgov)	临床2期	恶心和呕吐 \| 恶心 \| 呕吐	64	Prochlorperazine (Prochlorperazine)	鏇願鬱齋鑰獵襯憲齋網 = 廠構窪鬱齋構鹹鹽鹽夢齋襯艱廠淵壓窪積繭窪 (壓獵蓋繭遞構鬱襯憲製, 遞網醖觸繭簾襯願膚繭 ~ 醖餘夢衊積簾簾艱願獵) 更多	-	2014-05-19
				Ondansetron (Ondansetron)	鏇願鬱齋鑰獵襯憲齋網 = 獵顧築艱齋窪淵願鹽網齋襯艱廠淵壓窪積繭窪 (壓獵蓋繭遞構鬱襯憲製, 簾夢夢網夢製淵鏇顧鹹 ~ 顧鏇範鹹顧鑰網繭壓蓋) 更多