A Phase Ib/ II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination with Giredestrant in Comparison with Abemaciclib and Giredestrant in Participants with Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer who Have Previously Progressed During or After a CDK4/6 Inhibitor

开始日期2025-12-20

申办/合作机构

Genentech, Inc.

NCT07214662

/ Not yet recruiting临床1期

A Phase Ia/Ib Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Patients With Locally Advanced Or Metastatic ER-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After CDK4/6 Inhibitor Therapy

This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer who have previously progressed during or after CDK 4/6 inhibitor therapy.

开始日期2025-12-15

申办/合作机构

Genentech, Inc.

NCT07100106

/ Recruiting临床1/2期

A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor

The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.

开始日期2025-10-07

申办/合作机构

Genentech, Inc.

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100 项与吉雷司群相关的专利（医药）

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项与吉雷司群相关的文献（医药）

2025-01-27·Annual Review of Medicine

New Oral Selective Estrogen Receptor Degraders Redefine Management of Estrogen Receptor–Positive Breast Cancer

Review

作者: Pathak, Neha ; Oliveira, Mafalda

Oral selective estrogen receptor degraders (SERDs) are pure estrogen receptor antagonists that have the potential to overcome common resistance mechanisms to endocrine therapy in estrogen receptor–positive breast cancer. There are currently five oral SERDs in published and ongoing clinical trials—elacestrant, camizestrant, giredestrant, imlunestrant, and amcenestrant—with more in development. They offer a reasonably well-tolerated oral therapy option with low discontinuation rates in studies. This review summarizes the currently available literature on this new class of drugs.

2024-12-12·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of Thiochroman Derivatives as Potent, Oral Selective Estrogen Receptor Degraders and Antagonists for the Treatment of Endocrine-Resistant Breast Cancer

Article

作者: Hu, Wenhao ; Yang, Yushe ; Meng, Xin ; Zhang, Dan ; Leng, Xin-Yu ; Lu, Zhengyu ; Lei, Xiang ; Sun, Lulu ; He, Yongqi ; Kong, Deyu

Selective estrogen receptor degraders (SERDs) deplete the ER signaling pathway via antagonism and degradation of ERα and represent a promising strategy to tackle endocrine resistance. Here, we report a new class of SERDs by pharmacological evolution of a selective estrogen receptor modulator, lasofoxifene. The structure-activity relationship study and efforts to circumvent the issue of human ether-a-go-go-related gene led to the identification of compounds 51. This bifunctional compound displayed broad activity across a vast array of cell backgrounds and was capable of effectively degrading and antagonizing wild-type ERα and clinically relevant ERα mutants. 51 exhibited favorable pharmacokinetic properties and good brain penetration, with a brain/plasma ratio of 3.05, and significantly suppressed the growth of tumor in a tamoxifen-resistant MCF-7 Tam1 xenograft model. Overall, the study demonstrates 51 as a highly potent, oral, and brain penetrant ER degrader and pure antagonist, showing a good potential in overcoming endocrine resistance.

2024-11-01·JOURNAL OF PHARMACEUTICAL SCIENCES

Use of differential scanning calorimetry as a rapid, effective in-process check method for impurity quantitation of an early clinical batch of Giredestrant (GDC-9545)

Article

作者: Nagapudi, Karthik ; Chakravarty, Paroma

Giredestrant (GDC-9545) is a selective estrogen receptor degrader (SERD) that was developed for treatment of ER+/HER2- metastatic breast cancer. An anhydrous crystalline tartrate salt was identified as the solid form suitable for clinical development. An early clinical batch of the active pharmaceutical ingredient (API)/drug substance failed to pass the GMP purity specifications owing to the presence of a substantial amount of high molecular weight impurities (oligomers), as determined by size exclusion chromatography. Several trial rework batches were manufactured using various re-slurry and recrystallization conditions to purge impurities in the drug substance to adhere to purity specifications. Based on the melting point depression of the API in presence of oligomers in these rework batches, a differential scanning calorimetry method was developed to quantify impurity content as a function of melting point onset of the API. This thermal analysis method was used as a surrogate for chromatography as a rapid, effective in-process check method for impurity quantitation to enable the timely release of the final reworked clinical batch. Post release, the % w/w oligomer value determined by calorimetry was in excellent agreement to that obtained by size exclusion chromatography.

167

项与吉雷司群相关的新闻（医药）

2025-12-10

·Firstwordpharma

SABCS25: Roche's oral SERD cuts risk of disease recurrence, death by 30% in early breast cancer

Roche's giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% versus standard-of-care endocrine therapy in people with oestrogen receptor (ER)-positive, HER2-negative, early-stage breast cancer, according to data presented Wednesday at the San Antonio Breast Cancer Symposium (SABCS).Levi Garraway, the company's chief medical officer, who called the efficacy of the oral selective oestrogen receptor degrader (SERD) in the Phase III lidERA study "transformational," said the data "underscores the potential of giredestrant to become a foundational endocrine therapy in early-stage ER-positive breast cancer, where the chance for cure is highest."Roche top-lined the trial as positive last month, noting that giredestrant achieved the study's primary endpoint of invasive disease-free survival (DFS), excluding second primary non-breast cancers, at an interim analysis. The company also said at the time that while overall survival data were immature, a "clear positive trend" was observed.The trial enrolled over 4100 patients with medium- or high-risk stage I-III disease, with participants randomised to receive adjuvant giredestrant or standard-of-care endocrine therapy.Additional findings presented at SABCS showed that the invasive DFS benefit was consistent across clinically relevant subgroups. At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the endocrine therapy group, while Roche's drug also demonstrated a 31% risk reduction of distant recurrence-free survival.The company added that gredestrant was well tolerated in the study, with no unexpected safety findings seen. "We look forward to sharing these results with health authorities around the world," Garraway said. At the recent European Society for Medical Oncology (ESMO) congress, Roche presented results from the Phase III evERA study, which was top-lined as positive in September. In the trial, the use of giredestrant in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer, who had been previously treated with a CDK4/6 inhibitor, was associated with median progression-free survival of 8.77 months versus 5.49 months for endocrine therapy plus everolimus. Speaking recently to FirstWord, Massimo Cristofanilli, director of breast medical oncology at Weill Cornell Medicine, said that while the findings from evERA position giredestrant as another promising second-line treatment option, the more practice-changing result comes from lidERA. Cristofanilli suggested that the trial succeeding at an interim analysis "has enormous implications because it means the drug was effective in reducing early recurrence in a group of patients who were high-risk."Roche is currently conducting three other late-stage studies of giredestrant across different treatment settings and lines of therapy, including the persevERA, pionERA and heredERA trials.

临床结果临床3期

2025-12-06

·乳腺科钱学珂医生

HR+/HER2 - 晚期乳腺癌口服 SERD 类药物临床研究进展与核心结论（一）

HR+/HER2 -乳腺癌是最常见的乳腺癌亚型，约占70%，该亚型对内分泌治疗具有天然敏感性。以CDK4/6抑制剂为基础的一线内分泌治疗，显著改善了晚期患者的预后，但仍有相当一部分患者会因肿瘤对内分泌治疗耐药而导致病情进展。雌激素受体基因（ESR1）编码雌激素受体α（ERα），其突变可导致ERα结构改变，引发ER受体非配体依赖的持续激活，进而驱动肿瘤增殖，最终导致内分泌治疗耐药。临床数据显示，ESR1突变在未经治疗的原发性乳腺癌中发生率不足3%，但在接受CDK4/6 抑制剂治疗的患者中，突变率可飙升至40%。作为内分泌治疗±CDK4/6 抑制剂治疗后最常见的获得性突变，ESR1突变与近一半的内分泌耐药病例密切相关[1]。既往针对ESR1突变乳腺癌的治疗，主要依赖注射用选择性雌激素受体降解剂（SERD）氟维司群，但疗效不尽如人意。氟维司群距离第二款SERD艾拉司群获批早20多年，意味着20年内SERD类药物研发并无进展。近年来，新一代口服SERD类药物研发取得突破性进展，显著改写了HR+/HER2 - 晚期乳腺癌的治疗格局，药物种类较多，研究入组人群也有相当大的差异，现将近年发布的口服SERD 类药物关键临床研究归纳总结如下。一、evERA Ⅲ 期研究（2025 ESMO）：CDK4/6i 经治人群二线（及后线）治疗新突破，ESR1突变及ITT 人群均显著获益。突破6个月大关研究设计：本研究旨在评估罗氏口服SERD药物Giredestrant（吉瑞司群）联合mTOR 抑制剂依维莫司，在CDK4/6抑制剂耐药后HR+/HER2 -晚期乳腺癌患者中的疗效与安全性。入组患者均接受过CDK4/6抑制剂联合内分泌治疗（无论治疗阶段为早期或晚期），研究将“Giredestrant+依维莫司”方案与“标准内分泌治疗+依维莫司”方案进行头对头比较，共纳入373例患者，其中约55%为ESR1突变人群。研究结果：中位随访18.6个月的结果显示，Giredestrant联合方案在ESR1突变亚组和全体意向治疗（ITT）人群中均展现出卓越疗效：在ESR1突变患者中，Giredestrant联合方案组的中位无进展生存期（mPFS）达到9.99个月，显著优于标准治疗组的5.45个月，疾病进展或死亡风险降低 63%（HR=0.38，95% CI: 0.27-0.54，p<0.0001），充分验证了Giredestrant对ESR1突变介导的内分泌耐药具有明确的针对性治疗作用；在 ITT 人群中，Giredestrant联合方案组mPFS为8.8个月，同样显著优于标准治疗组的5.5个月，疾病进展或死亡风险降低44%（HR=0.56，95% CI: 0.44-0.71，p<0.0001）。总生存期（OS）数据虽尚未完全成熟，但在ITT人群和ESR1突变亚组中均呈现出明显的阳性获益趋势。安全性方面，Giredestrant联合依维莫司方案的安全性可控，未出现新的安全性信号。 evERA研究的成功，确立了Giredestrant+依维莫司这一全口服双靶点联合方案在CDK4/6 抑制剂耐药后的HR+/HER2 -晚期乳腺癌治疗中的地位。该方案可同时针对ESR1突变和PI3K/AKT/mTOR通路这两大最常见的耐药机制，兼具强效性与便捷性[2]。（目前，Giredestrant的临床研究布局已覆盖多个治疗场景：早期乳腺癌辅助治疗（lidERA Breast Cancer 研究）、内分泌敏感一线人群联合 CDK4/6 抑制剂（persevERA Breast Cancer 研究）、辅助内分泌治疗耐药一线人群联合 CDK4/6 抑制剂（pionERA Breast Cancer 研究），以及晚期 HR+/HER2 + 三阳性乳腺癌联合曲妥珠单抗 + 帕妥珠单抗双靶治疗（heredERA Breast Cancer 研究）。此前全球多中心pionERA Breast Cancer 研究已在我院开展过患者招募）二、EMERALD Ⅲ 期研究：CDK4/6i 经治后二线及后线治疗，单药艾拉司群获益局限于 ESR1突变人群，单药艾拉司群在先前接受CDK4/6i治疗持续时间＞12个月的患者中才突破6个月大关，虽写进NCCN指南但是适应人群太窄。研究设计：评估口服SERD药物elacestrant（艾拉司群）单药在CDK4/6抑制剂耐药后 HR+/HER2 -晚期乳腺癌患者中的疗效与安全性。入组患者需在既往接受过1~2线内分泌治疗中包含CDK4/6抑制剂（全CDK4/6i经治人群），且在晚期或转移性阶段接受过不超过1线化疗。研究将elacestrant单药与标准内分泌治疗（氟维司群，n=166；芳香化酶抑制剂，n=73）进行对比，共纳入478例患者（含男性及女性患者），其中228例（48%）为ESR1突变人群（采用Guardant360 CDx检测循环肿瘤DNA（ctDNA）确定ESR1突变状态，突变类型限定为配体结合域错义突变）。研究结果： ESR1突变的患者：在228名(48%)有ESR1突变的患者中，elacestrant组的中位PFS为3.8个月(95% CI: 2.2, 7.3)，而氟维司群或芳香酶抑制剂组的中位PFS为1.9个月(95% CI: 1.9, 2.1)，HR为0.55 [95% CI: 0.39, 0.77]，p=0.0005。进一步对接受CDK4/6i治疗持续时间的细化分析显示，对于ESR1突变患者而言，先前接受CDK4/6i治疗持续时间＞12个月的患者中才有治疗效果,艾拉司群的mPFS为8.6个月，而SOC的mPFS仅有不到2.1个月。 ITT人群中：艾拉司群组与标准治疗组相比较，中位PFS 2.79月vs 1.91月（HR=0.697 ，95%CI: 0.552～0.88；P=0.0018）无ESR1突变患者：在250名（52%）无ESR1突变患者中，HR为0.86（95% CI：0.63，1.19），表明ITT人群的改善主要归因于ESR1突变人群中观察到的结果。尽管艾拉司群已被写入NCCN指南，但其单药治疗的疗效数据并不理想，临床应用需结合患者ESR1突变状态进行筛选[3]。三、EMBER-3 Ⅲ 期研究（2024 SABCS；2025 ESMO亚组数据）：CDK4/6i 经治后二线治疗，联合方案疗效显著优于单药，联合组达9个月的PFS，且无需区分ESR1包括PAM通路突变状态。研究设计：EMBER-3研究共纳入874例HR+/HER2 -晚期乳腺癌患者，均为辅助或转移性阶段接受AI±CDK4/6抑制剂治疗后疾病进展的内分泌耐药人群。患者按1:1:1比例随机分配至Imlunestrant单药组、标准内分泌治疗组（氟维司群或依西美坦）及Imlunestrant+阿贝西利组（选择阿贝西利毕竟是自家药）。其中，两个Imlunestrant治疗组中大多数患者（n=279，65%）既往接受过CDK4/6抑制剂治疗，且该部分人群中37%存在ESR1突变、40%存在PI3K通路突变，70%的患者接受CDK4/6抑制剂治疗时长≥12个月。研究主要终点为研究者评估的Imlunestrant组与标准治疗组在ESR1突变和所有患者中的PFS，以及Imlunestrant+阿贝西利组与Imlunestrant组在所有患者中的PFS。研究结果：明确了联合治疗优于单药治疗的核心结论。在主要研究终点中，ESR1突变人群中Imlunestrant单药组mPFS为5.5个月（95% CI: 3.9-7.4），略优于标准治疗组的3.8个月（95% CI: 3.7-5.5），但总人群中未观察到显著差异；但是无论在总人群还是CDK4/6抑制剂经治人群中，Imlunestrant联合阿贝西利组均较Imlunestrant单药组展现出显著PFS获益，Imlunestrant+阿贝西利是治疗方案的首选。那么在目前CDK4/6i的一线治疗格局之下，我们更需要关注的是本研究中CDK4/6i经治的人群这一关键亚组的数据，结果显示，Imlunestrant联合阿贝西利组mPFS达到9.1 个月，显著优于Imlunestrant单药组的3.7个月（HR=0.51，95% CI: 0.38-0.68）。同时，不管是在ESR1突变还是PI3K通路突变、还是ESR1与PI3K通路双突变患者中均表现出一致的效果，无论既往CDK4/6i治疗持续时间或类型如何，均可观察到Imlunestrant+阿贝西利组较单药 Imlunestrant组的获益[4]。适用人群广泛，不用测靶点，数据又好，此药很值得看好。目前，礼来公司的Imlunestrant已在国内提交上市申请，申报适应症为：用于既往接受内分泌治疗的ER+/HER2-局部晚期或转移性乳腺癌患者（无论ESR1突变状态如何）[4]。下一篇将另外两个药物的相关研究给予展示，并且对全部药物数据给予总结和对比，真的口服SERD的新药太多了，数据也比之前的都好，内分泌耐药后的靶向治疗值得期待。 1 Meisel J L, et al. Real-world estrogen receptor 1 (ESR1) testing patterns and results in U.S. patients with metastatic breast cancer, 2018-2024. JCO Oncol Pract 2025;21:579-579. 2 Primary results of the Phase III evERA BC trial. Presented at: ESMO Congress; 2025 October 17-21; Berlin, Germany. LBA #16. 3 Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, García Sáenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortés J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 May 18:JCO2200338. doi: 10.1200/JCO.22.00338. Epub ahead of print. PMID: 35584336. 4 Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant with or without Abemaciclib in Advanced Breast Cancer. N Engl J Med. 2024 Dec 11. doi: 10.1056/NEJMoa2410858.

临床3期临床结果临床2期

2025-12-04

·医脉通肿瘤科

剑指治愈：lidERA BC研究报阳！罗氏口服SERD实现从晚期到早期跨越，有望重塑HR+乳腺癌全程管理格局

前言近期，罗氏宣布关键lidERA BC研究[1]取得重磅阳性结果，giredestrant成为全球首个在HR+/HER2-早期乳腺癌辅助治疗中，实现无浸润性疾病生存期（iDFS）统计学与临床意义双重显著的口服选择性雌激素受体降解剂（SERD），填补了口服SERD在早期辅助治疗领域的空白。继evERA BC研究[2]在晚期CDK4/6抑制剂经治的耐药人群证实获益后，这一结果标志着口服SERD完成了从晚期解救到早期治愈的关键跨越。 Giredestrant的突破性进展并非孤证，而是罗氏乳腺癌全周期布局的重要组成部分。近二十多年来，从覆盖HER2阳性、TNBC等亚型的靶向与免疫治疗药物，到HR+/HER2-领域构建起完整证据链条，罗氏的乳腺癌诊疗布局正在日益完善。李滨博士（左）、沈淑仪博士（右）正在分享为深度解码lidERA BC研究的划时代价值、解析罗氏乳腺癌领域的战略布局，医脉通特邀罗氏制药中国医学事务副总裁李滨博士与罗氏全球产品开发中国中心临床科学负责人沈淑仪博士，共同剖析该研究成果的突破性临床价值与重点患者人群获益，分享罗氏以患者需求为核心的研发战略远见，展望乳腺肿瘤诊疗新方向。医脉通：lidERA BC研究的成功给全球乳腺癌临床实践带来了哪些关键意义？giredestrant从晚期治疗成功走向早期辅助治疗，这一突破背后体现了罗氏怎样的研发策略与临床设计智慧？沈淑仪博士 evERA BC研究已证实giredestrant能为CDK4/6抑制剂经治的晚期患者，包括存在ESR1突变耐药的患者带来显著获益，满足了晚期治疗的需求。而lidERA BC研究作为首个此类药物在早期辅助治疗中取得阳性结果的III期研究，其意义更为深远。不仅标志着HR+早期乳腺癌治疗从相对同质化走向“精准强化”，为中高危患者提供了更优选择；更有望通过其疗效与可耐受性优化长期管理，在关键窗口期内为患者奠定更坚实的治愈基础，直击“远期复发”的临床痛点，主动干预并改写疾病长期病程。李滨博士这背后体现了罗氏深刻的科学洞见与前瞻的研发勇气。我们不仅追求延长晚期患者生命，更追求早期患者的“治愈”，因此致力于在早期在微转移阶段就有效扼制高危因素，推动该疾病真正走向治愈。同时，开展这样一项耗时久、投入大的早期辅助治疗研究，需要打破现状的决心，这体现了我们从“跟跑”迈向“领跑”的努力。此外，我们也致力于构建从早期到晚期的完整证据链，以期在全疾病周期为患者提供精准的解决方案。医脉通：在这一关键研究背后，有哪些令人印象深刻的研发故事或经历？沈淑仪博士每一项研究的成功都凝聚着不懈的探索与严谨求实的精神。对于giredestrant而言，其研发始于对雌激素受体结构的深刻理解，通过精密的构效关系研究，才设计出这款兼具高效降解活性与良好口服生物利用度的分子［3］，为后续开发奠定了坚实基础。回顾整个临床开发计划（CDP），有两点令我尤为深刻。其一是在II期coopERA研究[4]中，作为概念验证（Proof of Concept）研究，我们创新地选择在新辅助治疗“机会窗口”（window of opportunity）内开展，以生物标志物Ki67的变化快速验证概念，为后续投入大规模III期研究提供了决定性信心。其二是在III期阶段，我们采取多个适应症平行推进的策略，尤其是大胆布局了样本量巨大的早期辅助治疗研究。这既体现了公司在竞争中的决心，更源于我们对HR+患者在不同疾病阶段真实需求的深刻认识，希望为尚处早期的患者争取治愈机会。医脉通：从HER2阳性领域二十余年的引领，到如今HR+/HER2-领域的重大突破（如伊那利塞、Giredestrant）。罗氏乳腺癌研发管线的背后体现了怎样的战略视野与研发初心？李滨博士罗氏的战略始终是“先患者之需而行”，针对不同类型与阶段的乳腺癌提供创新方案。在HER2+领域，我们从确立联合治疗标杆到开发便捷的皮下制剂，是一个从“做加法”到“做减法”以提升患者生活质量的过程。在HR+领域，我们打出“组合拳”以构建全周期精准防线：包括针对PIK3CA突变的精准药物伊那利塞、作为基石药物的口服SERD giredestrant，以及针对CDK4/6抑制剂耐药而引入的CDK4/2抑制剂RGT-419B等。对于三阴性乳腺癌（TNBC），我们也通过自研与合作进行多维攻坚，力争为每一位患者提供综合性治疗方案。医脉通：过去，罗氏与中国乳腺学界的长期合作取得了有目共睹的成就。您如何看待这一历程？未来，您认为可在哪些方面继续开展更深层次的协作？沈淑仪博士这是一段共同成长的振奋历程。中国研究者已从早年临床研究的“执行者”逐步蜕变为如今全球研发的“共同创造者”，能够将中国的临床实践洞见有效融入全球研发体系与试验方案设计中。展望未来，我们期望中国不仅能继续在III期研究中发挥关键作用，更能深入参与从早期剂量探索到概念验证的全临床开发计划，将中国临床思路融入早期研究。李滨博士我们将秉持“从中国为中国，从中国为全球”（In China for China；In China for Global）的理念，从三方面深化协作。一是搭建“创新桥梁”，通过合作引入本土优秀创新产品并助力其走向全球。二是打造“能力平台”，共建研究者发起的研究（IIT）合作平台，将中国经验转化为全球证据。三是培育“人才沃土”，通过赋能合作助力中国临床研究能力提升，推动中国乳腺癌诊疗实现从“参与”到“引领”的跨越。医脉通：未来，罗氏将如何继续巩固其在乳腺癌领域的前沿引领地位，继续惠及更多中国患者？李滨博士首先，我们将持续深化创新药物的研发与拓展，强化在各亚型、各临床阶段的布局。其次，我们将探索“诊疗管”一体化的综合解决方案，从药物治疗、诊断分型到疾病管理，提供全周期管理赋能。最后，我们将持续赋能中国专家，助力其临床研究能力提升，实现从“并跑”到“领跑”。未来期望产出更多能影响全球指南的高质量中国证据，最终将中国患者的预后提升至全新高度。参考文献 [1] https://clinicaltrials.gov/study/NCT04961996 [2] Mayer E, et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial. ESMO 2025. LBA #16. [3] Liang J, et al. X. GDC-9545 (Giredestrant): A Potent and Orally Bioavailable Selective Estrogen Receptor Antagonist and Degrader with an Exceptional Preclinical Profile for ER+ Breast Cancer. J Med Chem. 2021 Aug 26;64(16):11841-11856. doi: 10.1021/acs.jmedchem.1c00847. Epub 2021 Jul 12. PMID: 34251202. [4] Hurvitz SA, et al. coopERA Breast Cancer study group. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023 Sep;24(9):1029-1041. 往期回顾 1.如何“点亮”乳腺癌治疗新纪元？罗氏制药中国高层独家专访，揭秘20年发展之路 | 20+20 廿廿有生 2.从“跟跑”到“领跑”！“临床+研发”巅峰对话，畅谈中国乳腺癌新药研发全球协作之路 | 20+20 廿廿有生 3.新靶点，新突破，新征程：中国首个PI3Kα抑制剂伊那利塞开启乳腺癌精准诊疗新时代 | 20+20 廿廿有生 4.20年奋进发展，20年激扬展望，PI3K靶点成就乳腺癌精准诊疗新界标 | 20+20 廿廿有生 5.双星闪耀时，Giredestrant与伊那利塞携手共探HR+乳腺癌诊疗新局面 | 20+20 廿廿有生撰写：Citrea 审校：River 排版：Sylvia 执行：Aurora 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，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。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

100 项与吉雷司群相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11961	-	-	-

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
ER阳性乳腺癌	临床3期	美国	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	日本	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	阿根廷	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	德国	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	希腊	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	意大利	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	新加坡	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	南非	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	韩国	Genentech, Inc.	2022-08-03
ER阳性乳腺癌	临床3期	西班牙	Genentech, Inc.	2022-08-03

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临床结果

适应症

分期

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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


NCT05659563 (EMPRESS, ESMO2025)	临床2期	ER阳性/HER2阴性乳腺癌 ER positive \| HER2 negative	92	Giredestrant 30 mg	鹽顧齋膚網壓網齋餘淵(簾廠選鹽鑰憲遞願願遞) = 鹹醖積鏇壓築觸獵範窪齋艱製繭製構鑰廠淵醖 (鏇壓齋範醖簾鬱選簾鹹, -17.5 ~ -13) 更多	积极	2025-10-17
				Tamoxifen 20 mg	鹽顧齋膚網壓網齋餘淵(簾廠選鹽鑰憲遞願願遞) = 構簾築襯鬱積蓋範淵廠齋艱製繭製構鑰廠淵醖 (鏇壓齋範醖簾鬱選簾鹹, -12.3 ~ -8.5) 更多
NCT05306340 (evERA Breast Cancer, Company_Website 1 \| Company_Website 2) 人工标引	临床3期	ER阳性/HER2阴性乳腺癌 \| 多发性骨髓瘤 \| HER2 阴性乳腺癌 HER2 Negative \| ESR1 Mutation \| ER Positive	72	giredestrant + everolimus	衊製鏇蓋鹽鹽衊糧憲鹽(選襯壓鬱鏇廠鑰夢艱衊) = demonstrating a statistically significant and clinically meaningful improvement in PFS in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus 選獵膚衊鬱範鏇衊襯簾 (糧簾構鏇網鏇窪鏇顧顧 ) 达到更多	积极	2025-09-22
				standard of care + everolimus
NCT04802759 (MORPHEUS Breast Cancer, ASCO2025)	临床1/2期	局部晚期乳腺癌一线 ESR1	60	Giredestrant (G) + Atezolizumab (ATEZO)	構夢簾淵製顧醖選簾積(衊鬱選範繭顧艱選簾獵) = 淵蓋遞醖觸築壓艱夢衊鹹獵網鬱築遞鹹鏇鏇簾 (廠繭積顧餘製鹹範襯衊 )	积极	2025-05-30
				Giredestrant (G) + Atezolizumab (ATEZO) + Abemaciclib (ABEMA)	構夢簾淵製顧醖選簾積(衊鬱選範繭顧艱選簾獵) = 築選鏇襯鹹鑰繭襯繭衊鹹獵網鬱築遞鹹鏇鏇簾 (廠繭積顧餘製鹹範襯衊 )
NCT04802759 (MORPHEUS- BREAST CANCER, ESMO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative \| ER Positive	33	Giredestrant 30 mg PO daily	築鏇繭鹹願窪窪範憲憲(鏇鬱鹽鏇衊糧窪觸窪膚) = 簾顧壓網衊廠構蓋鏇蓋衊襯糧襯選網鑰衊製淵 (簾鏇餘願壓衊襯膚艱顧 ) 更多	积极	2024-09-16
				Giredestrant 30 mg PO daily + Samuraciclib 360 mg PO daily	築鏇繭鹹願窪窪範憲憲(鏇鬱鹽鏇衊糧窪觸窪膚) = 築齋齋壓鑰襯鹹壓廠鹹衊襯糧襯選網鑰衊製淵 (簾鏇餘願壓衊襯膚艱顧 ) 更多
NCT04576455 (acelERA BC study, Pubmed) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌 Estrogen Receptor-Positive \| HER2-Negative	303	Giredestrant	選餘艱淵襯壓廠夢齋憲(醖獵窪範製網網淵壓簾): HR = 0.81 (95% CI, 0.6 ~ 1.1), P-Value = 0.1757 更多	积极	2024-06-20
				fulvestrant choice of endocrine monotherapy
NCT04802759 (ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative	15	Giredestrant (G) + Everolimus (EVERO)	糧網鹹糧齋夢獵糧範鹽(膚繭築構遞衊憲獵餘壓) = 獵憲鹹襯鏇鹽網獵憲鬱遞築鹽觸壓衊糧獵餘廠 (顧範襯艱範遞壓鹽顧窪 ) 更多	积极	2024-05-24
NCT03332797 (GO39932, Pubmed)	临床1期	ER阳性/HER2阴性乳腺癌 ER+ \| HER2-negative \| ESR1-mutated tumors	175	Giredestrant 10 mg	艱範顧鹹憲壓醖蓋願廠(艱製醖齋鬱襯鹹遞遞淵) = 鹽糧蓋窪網壓築鬱積廠遞艱壓遞壓獵壓選醖夢 (範選壓獵淵積構顧廠獵 )	积极	2024-01-23
				Giredestrant 30 mg	艱範顧鹹憲壓醖蓋願廠(艱製醖齋鬱襯鹹遞遞淵) = 齋膚廠獵鑰顧願襯淵鹹遞艱壓遞壓獵壓選醖夢 (範選壓獵淵積構顧廠獵 )
NCT03332797 (phase Ia/Ib dose-escalation/-expansion study, Pubmed \| Cancer Res Commun)	临床1期	晚期乳腺癌	-	Giredestrant 10 mg	鏇壓憲鑰繭齋壓衊窪衊(獵醖積襯淵齋醖襯範願) = 夢醖鹽鹹積衊鑰製窪簾廠襯鏇獵餘齋鏇壓膚淵 (襯鑰鏇選蓋糧膚鹹蓋衊 )	积极	2023-12-15
				Giredestrant 30 mg	鏇壓憲鑰繭齋壓衊窪衊(獵醖積襯淵齋醖襯範願) = 膚築夢齋鏇壓餘鑰膚憲廠襯鏇獵餘齋鏇壓膚淵 (襯鑰鏇選蓋糧膚鹹蓋衊 )
NCT04436744 (coopERA Breast Cancer, Pubmed \| Lancet Oncol)	临床2期	ER阳性/HER2阴性乳腺癌新辅助 oestrogen receptor-positive \| HER2-negative \| Ki67 score	221	Giredestrant 30 mg	鹹網蓋餘簾齋網壓願齋(鏇蓋膚鹹積夢簾築顧構) = 範壓範鹽夢淵構糧鹹觸壓顧廠醖艱襯衊製淵膚 (鏇繭醖鑰顧糧鹽鹽鬱鬱, -80 ~ -70)	积极	2023-09-01
				Anastrozole 1 mg	鹹網蓋餘簾齋網壓願齋(鏇蓋膚鹹積夢簾築顧構) = 顧齋餘觸艱網艱簾餘鬱壓顧廠醖艱襯衊製淵膚 (鏇繭醖鑰顧糧鹽鹽鬱鬱, -73 ~ -59)
NCT04802759 (MORPHEUS BC, ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 ER Positive \| HER2 Negative	40	Abemaciclib+Giredestrant	淵鏇築襯簾範觸齋願繭(鹹觸壓鑰觸鹹簾夢醖遞) = 膚願積鏇淵選鹽顧壓襯襯願憲醖顧憲構鬱積衊 (艱窪鬱糧遞壓築醖糧鹽 ) 更多	积极	2023-05-26
				ribociclib +Giredestrant	淵鏇築襯簾範觸齋願繭(鹹觸壓鑰觸鹹簾夢醖遞) = 齋糧製艱積憲鹽構製蓋襯願憲醖顧憲構鬱積衊 (艱窪鬱糧遞壓築醖糧鹽 ) 更多