更新于：2024-11-21
Tamoxifen
更新于：2024-11-21
概要
基本信息
非在研机构- |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构
分子式C26H29NO |
InChIKeyNKANXQFJJICGDU-QPLCGJKRSA-N |
CAS号10540-29-1 |
关联
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项与 Tamoxifen 相关的临床试验A Pilot Study of Chemoprevention With Tamoxifen in Patients With Pre-Invasive Pancreas Mucinous Cystic Neoplasms Who Will Not Undergo Immediate Resection
This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic mucinous cystic neoplasms (MCN) who will not undergo immediate resection. Up to 15 participants will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks.
开始日期2024-11-01 |
申办/合作机构 |
Refining Tamoxifen Dose for Premenopausal Breast Cancer Risk Reduction (RENAISSANCE): A Phase II Single Arm Trial
This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.
开始日期2024-09-19 |
申办/合作机构 |
Randomized Double Blind Phase 2 Trial of Baby Tamoxifen Versus Baby Exemestane in Post-menopausal Women at High Risk for Breast Cancer. BabyTEARS (Baby Tamoxifen or Exemestane Assessment Randomized Study)
The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life.
开始日期2024-09-01 |
申办/合作机构 |
100 项与 Tamoxifen 相关的临床结果
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100 项与 Tamoxifen 相关的转化医学
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100 项与 Tamoxifen 相关的专利（医药）
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3,674
项与 Tamoxifen 相关的文献（医药）2025-01-01·Brain, Behavior, and Immunity
Pericyte ablation causes hypoactivity and reactive gliosis in adult mice
Article
作者: Cullen, Carlie L. ; Fortune, Alastair J ; Brown, Lachlan S ; Morris, Gary P. ; Makowiecki, Kalina ; Morris, Gary P ; Young, Kaylene M. ; Sutherland, Brad A ; Young, Kaylene M ; Brown, Lachlan S. ; Cashion, Jake M. ; Premilovac, Dino ; Sutherland, Brad A. ; Fortune, Alastair J. ; Courtney, Jo-Maree ; Cullen, Carlie L ; Cashion, Jake M
2025-01-01·Maturitas
Menopausal symptoms in breast cancer survivors on adjuvant endocrine therapy compared with those of menopausal women
Article
作者: Del Mastro, Lucia ; Massarotti, Claudia ; Cagnacci, Angelo ; Londero, Ambrogio P ; Xholli, Anjeza ; Asinaro, Giorgia ; Anserini, Paola ; Londero, Ambrogio P. ; Lambertini, Matteo
2025-01-01·Bone
Downregulation of Krüppel-like factor 15 expression delays endochondral bone ossification during fracture healing
Article
作者: Kamenaga, Tomoyuki ; Kuroda, Yuichi ; Matsumoto, Tomoyuki ; Tachibana, Shotaro ; Maeda, Takuma ; Tsubosaka, Masanori ; Ogawa, Wataru ; Wada, Kensuke ; Hosooka, Tetsuya ; Ikuta, Kemmei ; Nakano, Naoki ; Suda, Yoshihito ; Hayashi, Shinya ; Saito, Akira ; Kuroda, Ryosuke ; Onoi, Yuma ; Anjiki, Kensuke
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项与 Tamoxifen 相关的新闻（医药）2024-11-14
Conference Call and Webcast Today at 4:30 p.m. ET Development Program Highlights and Anticipated Milestones Ovaprene® hormone-free monthly intravaginal contraceptive candidate – pivotal Phase 3 contraceptive efficacy study recruiting across the United States; foundation grant announced yesterday will provide funding to allow Daré to expand the number of clinical sites to accelerate the development timeline Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousal disorder - continued operational progress toward a planned Phase 3 study, including constructive discussions with FDA; Phase 3 design, development, and collaboration strategy updates DARE-HPV proprietary, fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases – conducting activities necessary to enable submission of an IND application to the FDA for a Phase 2, randomized, placebo-controlled, double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women, which will be supported with funding Daré receives as an ARPA-H Sprint for Women’s Health $10 million awardee DARE-VVA1 proprietary formulation of tamoxifen for intravaginal administration being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe dyspareunia, or pain during sexual intercourse – conducting activities in preparation for a Phase 2 clinical study of DARE-VVA1 based on Daré's FDA-cleared IND DARE-PTB1 intravaginal ring designed to deliver bio-identical progesterone continuously for up to 14 days for the prevention of preterm birth – conducting activities necessary to enable submission of an IND application to the FDA for a Phase 1 clinical study, which will be supported by a $2 million grant from NICHD Foundation grant of up to approximately $10.7 million to fund activities related to the identification and development of a novel non-hormonal intravaginal contraceptive product candidate and to add additional clinical sites to accelerate the ongoing Ovaprene® pivotal study. SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today reported financial results for the quarter ended September 30, 2024 and provided a company update. “We continue to be excited about the increased attention on the health and wellbeing of women, including by the Advanced Research Projects Agency for Health (ARPA-H) as evidenced by their recent announcement related to the awardees of the ARPA-H Sprint for Women’s Health and our announcement of the $10 million award we were selected to receive for DARE-HPV, an innovative investigational treatment for HPV-related cervical diseases. Essentially all cervical cancer cases worldwide are caused by HPV infection. We are also very pleased by the foundation’s continued commitment to invest in the development of non-hormonal contraceptive methods as evidenced by the grant we announced yesterday of up to approximately $10.7 million to fund activities related to our identification and development of a novel non-hormonal intravaginal contraceptive product candidate and to add additional clinical sites to accelerate the ongoing Ovaprene® pivotal study.” “We continue to execute on our mission to accelerate development of and bring to market innovative treatments that women want and need by advancing our late-stage candidates – all of which represent a first-in-category opportunity – as we seek to deliver value for all Daré stakeholders. In addition to the continued commercialization by our collaborator Organon of XACIATO™ (clindamycin phosphate) vaginal gel 2%, the first FDA-approved product to emerge from our portfolio and a treatment for bacterial vaginosis in females aged 12 and older* that is available by prescription nationwide, we continue to advance our first-in-category Phase 3 development candidates with ongoing enrollment in our Phase 3 study of Ovaprene at sites across the U.S., and continued constructive interactions with the FDA focused on aligning on the Phase 3 program for Sildenafil Cream 3.6% in female sexual arousal disorder. Despite its high prevalence, there are currently no FDA-approved treatments for female sexual arousal disorder and we look forward to advancing this program into Phase 3. Additionally, we are conducting activities in preparation for a Phase 2 clinical study of DARE-VVA1 and a Phase 1 study of DARE-PTB1, which is supported by a $2 million grant from NICHD,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The progress across our portfolio, along with the $10.7 million grant agreement announced yesterday, the $10 million award from ARPA-H announced in October, the $15 million equity line arrangement we established with Lincoln Park Capital Fund, LLC in October, and the $22 million we secured in the non-dilutive strategic royalty financing in the second quarter, put Daré on track for meaningful milestones in 2025.” *Please see below for important safety and other information. Ovaprene® Phase 3 StudyOvaprene is a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) and commercial collaborator Bayer, Daré commenced patient enrollment in the Ovaprene® pivotal Phase 3 clinical study in December 2023. Non-hormonal contraception represents a significant commercial market opportunity, and there are currently no monthly, hormone-free contraceptives approved by the U.S. Food and Drug Administration (FDA). Ovaprene® has potential to be a disruptive product in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to do so. Recruitment is currently proceeding at 10 sites across the United States, supported by a central advertising campaign for the study that launched in March 2024. Based on the current average enrollment rate, Daré anticipates that approximately half of its target number of participants to complete the study, or 125 women, will complete approximately 6 months of product use by the end of the second quarter of 2025. The foundation grant announced yesterday will provide funding to allow Daré to expand the number of clinical sites recruiting in the study, which is intended to accelerate the overall development timeline. Sildenafil Cream, 3.6% Progress toward Phase 3 StudySildenafil Cream is a proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical on-demand administration to treat female sexual arousal disorder (FSAD). Daré completed all study analyses of data from the exploratory Phase 2b RESPOND clinical study and held an end-of-Phase 2 meeting with the FDA in December 2023. In prior quantitative studies, Sildenafil Cream increased genital tissue blood flow, and the Phase 2b at-home study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and the questions to ask them that best reflect that improvement. The patient population and the endpoints proposed to the FDA for Phase 3 clinical development were those where Daré's exploratory post-hoc analyses of the Phase 2b study data showed that Sildenafil Cream demonstrated statistically significant and meaningful patient improvement. Ongoing discussions with the FDA are focused on aligning on primary and secondary patient reported outcome endpoints for the Phase 3 studies as well as other data that might be required for a new drug application (NDA) submission. Based on FDA feedback Daré has received, two successful Phase 3 clinical studies of Sildenafil Cream will be required to support an NDA for Sildenafil Cream for the treatment of FSAD, and Daré anticipates that each Phase 3 study will be approximately $15.0 million in direct costs. Daré will take into account its capital resources before initiating a Phase 3 study. Daré’s planned initial Phase 3 study of Sildenafil Cream, 3.6% would be the first ever Phase 3 pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. Daré intends to provide updates on the Phase 3 program, as well as relevant updates on the initial Phase 3 study timing and Daré’s collaboration strategy as they become available. Financial Highlights for the Quarter ended September 30, 2024 Cash and cash equivalents: $11.2 million at September 30, 2024. General and administrative expenses: $2.0 million in 3Q-2024 as compared to $2.7 million in 3Q-2023, with the current quarter’s decrease primarily attributable to reduced professional services expense and reduced commercial readiness expenses. Research and development expenses: $2.7 million in 3Q-2024 as compared to $6.7 million in 3Q-2023, a 60% decrease compared to Q3-2023, with the current quarter’s decrease primarily attributable to a decrease in costs related to development activities for Sildenafil Cream as a result of the Phase 2b RESPOND clinical study completion in June 2023, partially offset by increases in costs related to Ovaprene’s development, including the ongoing pivotal Phase 3 clinical trial. Conference Call Daré will host a conference call and live webcast today, November 14, 2024, at 4:30 p.m. Eastern Time to review financial results for the quarter ended September 30, 2024 and to provide a company update. To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free). The conference ID number for the call is 6400145. The live webcast can be accessed under “Presentations, Events & Webcasts” in the Investors section of the company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under “Presentations, Events & Webcasts” in the Investors section of the company's website at http://ir.darebioscience.com and available for replay until November 28, 2024. About XACIATO™ (clindamycin phosphate) vaginal gel 2% XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older. A single-dose user-filled disposable applicator delivers 5g of vaginal gel containing 100mg of clindamycin. Selected Safety Information XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used. XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis, which may require antifungal treatment. The most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort. XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug. There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition. Please see the Prescribing Information, Patient Information, and Instructions for Use. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious diseases, and menopause. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré’s full portfolio of women’s health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. Forward-Looking Statements Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “project,” “target,” “objective,” “on track,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to plans and expectations with respect to Daré’s product candidates, including clinical development plans, trial design, timelines, costs, milestones, targeted indications, anticipated regulatory approval pathways, and potential alignment with the FDA on requirements for a successful NDA submission, the potential for FDA approval of Ovaprene based on a single pivotal clinical study, the expectation that a product candidate, if approved, could be a first-in-category product, the potential market size and opportunity for a product candidate, if approved, the amount and timing of Daré’s receipt of funds under the recently announced foundation grant agreement, Daré’s anticipated use of funds it receives and Daré’s expectations with respect to the impact of such grant funding on its Ovaprene development program, the expectation that Daré will receive $10 million in funding under ARPA-H’s Sprint for Women’s Health, Daré’s ability to access $15 million in additional capital under its equity line arrangement with Lincoln Park Capital Fund at times and in amounts it desires to help advance development of its investigational products, and the potential for Daré’s product candidates to demonstrate they are safe and effective for their respective target indications. As used in this press release, the description of a product candidate as “first-in-category” is a forward-looking statement relating to the potential of the candidate to represent a new category of product if it were to receive marketing approval for the indication for which Daré is developing it. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to achieve the product development and other milestones required for it to receive payments under its ARPA-H funding award and grant agreements with the foundation; the limits on Daré’s ability to sell stock to Lincoln Park Capital Fund under the purchase agreement at times it may desire to raise additional capital; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s ability to add new clinical study sites to the Ovaprene pivotal study and the ability of such additional sites to enroll subjects in a manner that accelerates the study timeline; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Daré Bioscience Investor Relationsinnovations@darebioscience.com Source: Daré Bioscience, Inc. Daré Bioscience, Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) Three months ended September 30, 2024 2023 Revenue
License fee revenue$- $1,000,000 Royalty revenue 41,691 -
Total revenue 41,691 1,000,000 Operating expenses
General and administrative 2,041,268 2,696,779 Research and development 2,656,772 6,674,636 License fee expense 25,000 25,000
Total operating expenses 4,723,040 9,396,415 Loss from operations (4,681,349) (8,396,415) Other income (expense) (21,152) 97,319 Net loss$(4,702,501) $(8,299,096) Foreign currency translation adjustments$22,935 $(15,030) Comprehensive loss$(4,679,566) $(8,314,126) Loss per common share:
Basic$(0.55) $(1.09) Diluted$(0.55) $(1.09) Weighted average number of shares outstanding:
Basic 8,534,433 7,587,637 Diluted 8,534,433 7,587,637
Daré Bioscience, Inc. and Subsidiaries Condensed Consolidated Balance Sheets Data September 30,2024 December 31,2023 (unaudited) Cash and cash equivalents$11,232,609 $10,476,056 Working capital (deficit)$1,790,546 $(2,936,897) Total assets$18,058,801 $21,282,215 Total stockholders' deficit$(1,484,483) $(5,047,640)
临床3期临床2期引进/卖出临床结果上市批准
2024-11-05
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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）
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临床结果临床2期抗体药物偶联物
2024-11-01
INDIANAPOLIS, Nov. 1, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from the Phase 3 trial (EMBER-3) for imlunestrant, an oral selective estrogen receptor degrader (SERD), will be reported for the first time in a late-breaking oral presentation at the San Antonio Breast Cancer Symposium (SABCS) taking place December 10-13 in San Antonio, TX. EMBER-3 is a study in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The trial is evaluating imlunestrant alone or in combination with Verzenio (abemaciclib; CDK4/6 inhibitor), in patients who were pretreated with endocrine therapy, with or without a CDK4/6 inhibitor.
Lilly will also share results of a real-world analysis of risk of recurrence by nodal status and high-risk features in patients with hormone receptor positive (HR+), HER2- early breast cancer. Additional presentations from investigational mutant selective PI3Ka inhibitor assets include preclinical characterization data for LY4045004, which is expected to enter the clinic in the first half of 2025, and Phase 1a/b clinical data for a predecessor molecule, LOXO-783, which informed the development of LY4045004.
A full list of abstract titles and viewing details are listed below:
Imlunestrant (investigational oral SERD)
Presentation Title: Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy and Combined with Abemaciclib, for Patients with ER+, HER2- Advanced Breast Cancer (ABC), Pretreated with Endocrine Therapy (ET): Results of the Phase 3 EMBER-3 trial.
Presentation Number: GS1-01
Presentation Date & Time: Wednesday, Dec.11, 2024, 9:15-9:30 a.m. CST
Location: Hall 1
Presenter: Komal Jhaveri
Presentation Title: Patient and health care provider perspectives on oral versus intramuscular endocrine therapy for locally advanced or metastatic breast cancer
Presentation Number: P4-03-11
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Rebecca Speck
Presentation Title: Evaluation of pharmacokinetics and safety of imlunestrant in participants with hepatic impairment
Presentation Number: P4-10-07
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Xuejing Aimee Wong
Real World Evidence
Presentation Title: Risk of Recurrence by Nodal Status and High-Risk Features in Patients with HR+, HER2-, Early Breast Cancer: An Analysis of Real-world Data
Presentation Number: P1-11-02
Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Sara Tolaney
Verzenio® (abemaciclib)
Presentation Title: Genomic profiling of ctDNA and association with efficacy in patients from the postMONARCH trial of abemaciclib + fulvestrant vs placebo + fulvestrant for HR+, HER2-, advanced breast cancer following progression on a prior CDK4/6i plus endocrine therapy
Presentation Number: P1-01-26
Presentation Date &Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Seth Wander
Presentation Title: Clinical Characteristics and Treatment Persistence in US Patients with HR+/HER2-, Node Positive Early Breast Cancer Treated with Abemaciclib: Real-World Study from First Year After Approval
Presentation Number: P1-11-29
Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Hatem Soliman
Presentation Title: Unveiling the Antitumor Mechanism of abemaciclib in Human Breast Cancer Through Circulating Tumor Chromatin Analysis
Presentation Number: P5-02-23
Presentation Date & Time: Friday, Dec.13, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Mamoru Takada
PI3Ka Inhibitor (LOXO-783)
Presentation Title: A first-in-human phase 1a/b trial of LOXO-783, a potent, highly mutant-selective, brain-penetrant, allosteric PI3Kα H1047R inhibitor advanced breast cancer and other solid tumors: Results from the PIKASSO-01 study
Presentation Number: PS7-03
Presentation Date & Time: Wednesday, Dec.11, 2024, 7-8:30 a.m. CST
Location: TBD
Presenter: Komal Jhaveri
Next-Gen PI3Ka Inhibitor (LY4045004)
Presentation Title: Preclinical characterization of LY4045004, a next-generation, mutant-selective PI3Kα inhibitor
Presentation Number: P4-12-24
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Raymond Gilmour (Lilly)
About Verzenio® (abemaciclib)
Verzenio® (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients. The National Comprehensive Cancer Network® (NCCN®) recommends consideration of two years of abemaciclib (Verzenio) added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.1 NCCN® also includes Verzenio plus endocrine therapy as a preferred treatment option for metastatic breast cancer.1
The collective results of Lilly's clinical development program continue to differentiate Verzenio as a CDK4/6 inhibitor. In high risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, an adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a high-risk population.2 In metastatic breast cancer, Verzenio has demonstrated statistically significant OS in the Phase 3 MONARCH 2 study.3 Verzenio has shown a consistent and generally manageable safety profile across clinical trials.
Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 counties around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at .
INDICATIONS FOR VERZENIO®
VERZENIO® is a kinase inhibitor indicated:
in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)
Severe
diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of diarrhea ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.
Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.
Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in <1% of patients exposed to Verzenio across trials. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.
Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Severe, life-threatening, or fatal
interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in EBC (monarchE), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients in MBC (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported.
Monitor patients for pulmonary symptoms indicative of ILD or pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations. Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD or pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.
Grade
≥
3 increases in alanine aminotransferase (ALT) (2 to 6%) and
aspartate aminotransferase (AST) (2 to 3%) were reported in patients receiving Verzenio. Across three clinical trials in 3559 patients (monarchE, MONARCH 2, MONARCH 3), the median time to onset of Grade ≥3 ALT increases ranged from 57 to 87 days and the median time to resolution to Grade <3 was 13 to 14 days. The median time to onset of Grade ≥3 AST increases ranged from 71 to 185 days and the median time to resolution to Grade <3 ranged from 11 to 15 days.
Monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or any Grade 3 or 4 hepatic transaminase elevation.
Venous thromboembolic events (VTE) were reported in 2 to 5% of patients across three clinical trials in 3559 patients treated with Verzenio (monarchE, MONARCH 2, MONARCH 3). VTE included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis. In clinical trials, deaths due to VTE have been reported in patients treated with Verzenio.
Verzenio has not been studied in patients with early breast cancer who had a history of VTE. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Dose interruption is recommended for EBC patients with any grade VTE and for MBC patients with a Grade 3 or 4 VTE.
Verzenio can cause
fetal harm when administered to a pregnant woman, based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for 3 weeks after the last dose. Based on findings in animals, Verzenio may impair fertility in males of reproductive potential. There are no data on the presence of Verzenio in human milk or its effects on the breastfed child or on milk production. Advise lactating women not to breastfeed during Verzenio treatment and for at least 3 weeks after the last dose because of the potential for serious adverse reactions in breastfed infants.
The
most common adverse reactions (all grades,
≥
10%) observed in
monarchE for Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an aromatase inhibitor, with a difference between arms of
≥
2%, were diarrhea (84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs 18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache (20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14% vs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT increased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash (11% vs 4.5%), and alopecia (11% vs 2.7 %).
The
most frequently reported
≥
5% Grade 3 or 4 adverse reaction that occurred in the
Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of monarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea (8% vs 0.2%), and lymphopenia (5% vs <1%).
Lab abnormalities (all grades; Grade 3 or 4) for
monarchE in
≥
10% for Verzenio plus tamoxifen or an aromatase inhibitor with a difference between arms of
≥
2% were increased serum creatinine (99% vs 91%; .5% vs <.1%), decreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil count (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased lymphocyte count (59% vs 24%; 13.2 % vs 2.5%), decreased platelet count (37% vs 10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31% vs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).
The
most common adverse reactions (all grades,
≥
10%) observed in
MONARCH 3 for Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a difference between arms of
≥
2%, were diarrhea (81% vs 30%), fatigue (40% vs 32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%).
The
most frequently reported
≥
5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of
MONARCH 3 were neutropenia (22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT (6% vs 2%), and anemia (6% vs 1%).
Lab abnormalities (all grades; Grade 3 or 4) for
MONARCH 3 in
≥
10% for Verzenio plus anastrozole or letrozole with a difference between arms of
≥
2% were increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%), decreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte count (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9% vs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs 23%; 3.8% vs 0.6%).
The
most common adverse reactions (all grades,
≥
10%) observed in
MONARCH 2 for Verzenio plus fulvestrant vs fulvestrant, with a difference between arms of
≥
2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%), thrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%), and weight decreased (10% vs 2.2%).
The
most frequently reported
≥
5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of
MONARCH 2 were neutropenia (25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (5.7% vs 3.5%).
Lab abnormalities (all grades; Grade 3 or 4) for
MONARCH 2 in
≥
10% for Verzenio plus fulvestrant with a difference between arms of
≥
2% were increased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood cells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%; 32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count (63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs 0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%; 3.9% vs 4.2%).
The
most common adverse reactions (all grades,
≥
10%) observed in
MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).
The
most frequently reported
≥
5% Grade 3 or 4 adverse reactions from
MONARCH 1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and leukopenia (5%).
Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were increased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased lymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased ALT (31%; 3.1%), and increased AST (30%; 3.8%).
Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. Patients should avoid grapefruit products.
Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.
With severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing frequency to once daily. The pharmacokinetics of Verzenio in patients with
severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr ≥30-89 mL/min).
Please see full
Prescribing Information
and
Patient Information
for Verzenio.
AL HCP ISI 12OCT2021
About Imlunestrant
Imlunestrant is an oral selective estrogen receptor (ER) degrader, that delivers continuous ER inhibition, including in ESR1-mutant cancers.
The estrogen receptor (ER) is the key therapeutic target for patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Novel degraders of ER may overcome endocrine therapy resistance while providing consistent oral pharmacology and convenience of administration. Imlunestrant is currently being studied as a treatment for advanced breast cancer and as an adjuvant treatment in early breast cancer, including: NCT04975308, NCT05514054
, NCT04188548, NCT05307705.
Verzenio® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
© Lilly USA, LLC 2024. ALL RIGHTS RESERVED.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn.
P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Verzenio® (abemaciclib), imlunestrant, LOXO-783 or LY4045004 as potential treatments for people with certain types of early breast cancer and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, or that Verzenio, imlunestrant, or LY4045004 will receive initial regulatory approvals or approvals for additional indications, as applicable, or that they will be commercially successful. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
SOURCE Eli Lilly and Company
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临床3期临床结果上市批准
100 项与 Tamoxifen 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 阴道疾病 | 临床1期 | - | 2023-09-21 | |
| 外阴和阴道萎缩 | 临床1期 | 澳大利亚 | 2021-11-22 | |
| 性交困难 | 临床申请批准 | 美国 | 2023-12-07 |
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临床结果
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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 |
|---|
N/A | - | (Uterine cancer patients) | 鑰壓蓋鬱鏇網壓夢積範(鑰願願醖鏇憲艱顧遞襯) = 艱鏇簾範築鑰鑰壓壓獵 膚壓繭顧繭構積餘構餘 (鑰簾艱糧膚製遞觸憲衊 ) | - | 2023-09-01 | ||
N/A | - | - | (Breast Cancer First) | 積築範觸範醖窪廠願壓(廠網鑰襯範餘衊觸糧窪) = 願遞遞齋鹽選鹽鹽餘鹽 艱壓觸願網鏇淵選餘鏇 (選構蓋築鑰壓繭憲夢淵 ) | - | 2016-06-01 | |
(Endometrial Cancer First) | 積築範觸範醖窪廠願壓(廠網鑰襯範餘衊觸糧窪) = 鹹齋構廠壓觸齋壓夢構 艱壓觸願網鏇淵選餘鏇 (選構蓋築鑰壓繭憲夢淵 ) | ||||||
N/A | - | (淵窪簾襯鹽蓋顧鏇衊艱) = 觸鹹範獵憲鹹醖衊選壓 鹽窪齋網觸鹹壓廠壓壓 (淵餘繭壓獵鏇餘鏇壓衊 ) 更多 | - | 2010-11-01 | |||
No Tamoxifen | (淵窪簾襯鹽蓋顧鏇衊艱) = 憲餘顧鏇鑰鑰衊簾壓窪 鹽窪齋網觸鹹壓廠壓壓 (淵餘繭壓獵鏇餘鏇壓衊 ) 更多 | ||||||
N/A | - | Radiotherapy plus Tamoxifen | 蓋願壓餘製繭壓鑰夢衊(遞築簾觸遞鬱獵壓網糧) = 夢積範鬱蓋襯網蓋鏇築 願壓廠蓋獵鹹製鹹願鑰 (鏇觸構夢範艱夢憲鑰顧 ) | - | 2007-11-01 | ||
N/A | 乳腺癌 ER/PR | 769 | (鹽窪鹽艱遞膚鹹繭窪夢) = 壓壓醖齋齋選鏇鏇壓獵 製簾築簾壓積艱餘範襯 (憲襯築範製鑰繭餘獵繭 ) 更多 | 积极 | 2006-11-01 | ||
Tamoxifen + Radiation | (鹽窪鹽艱遞膚鹹繭窪夢) = 壓餘壓鏇鹹糧襯簾窪襯 製簾築簾壓積艱餘範襯 (憲襯築範製鑰繭餘獵繭 ) 更多 | ||||||
N/A | - | - | Tamoxifen and radiation therapy (RTTAM) | 築構齋膚膚餘繭築襯壓(艱獵獵構選壓壓壓鬱顧) = 遞夢鏇繭夢憲蓋鑰窪襯 選醖願鏇齋艱獵鬱膚餘 (願鏇襯簾窪鹹衊遞範淵 ) | - | 2005-10-01 | |
鹽壓衊範積廠網夢膚憲(壓顧網選遞鑰廠鬱範鬱) = 憲衊繭壓築遞鹽窪醖壓 膚獵鹽醖衊遞鑰壓艱膚 (鏇鏇製鬱壓鹹遞遞遞繭 ) 更多 | |||||||
N/A | - | - | 餘築艱簾遞廠遞遞窪淵(範顧願鹹餘憲繭範夢願) = 醖簾糧夢鑰繭廠醖餘窪 鹹獵鏇簾壓醖醖簾襯願 (鬱選鑰構蓋鑰夢壓淵鑰 ) 更多 | - | 2005-10-01 | ||
餘築艱簾遞廠遞遞窪淵(範顧願鹹餘憲繭範夢願) = 製鏇獵醖膚簾鏇窪襯糧 鹹獵鏇簾壓醖醖簾襯願 (鬱選鑰構蓋鑰夢壓淵鑰 ) 更多 | |||||||
N/A | - | Tamoxifen + Radiation Therapy | (餘齋遞餘糧鏇範顧廠窪) = 簾鬱憲壓積襯網糧壓構 顧衊構築鏇夢憲壓衊淵 (選蓋願廠構艱積艱糧獵 ) 更多 | - | 2004-09-01 | ||
Tamoxifen alone | (餘齋遞餘糧鏇範顧廠窪) = 顧獵簾糧網淵艱繭繭獵 顧衊構築鏇夢憲壓衊淵 (選蓋願廠構艱積艱糧獵 ) 更多 | ||||||
N/A | - | Radiation therapy + Tamoxifen | 鬱積糧願糧壓鬱獵構構(窪願衊鹽選選糧淵選願) = 糧獵選獵選繭鹽範鏇壓 獵艱鹽膚鬱繭鑰糧蓋壓 (遞糧遞繭廠繭壓蓋鹹衊 ) 更多 | - | 2002-10-01 | ||
Tamoxifen alone | 鬱積糧願糧壓鬱獵構構(窪願衊鹽選選糧淵選願) = 鏇淵壓鹽製窪艱鏇築鑰 獵艱鹽膚鬱繭鑰糧蓋壓 (遞糧遞繭廠繭壓蓋鹹衊 ) 更多 | ||||||
N/A | - | - | Mastectomy and chemotherapy (+/- tamoxifen) | 壓廠壓範積窪憲鹽壓淵(衊糧範觸餘願範衊簾顧) = 遞簾齋壓襯願窪醖構範 製憲簾壓醖顧壓築憲鹹 (壓齋鬱醖網鹹築憲構齋 ) 更多 | - | 2002-10-01 |
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