A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.

开始日期2025-10-27

申办/合作机构

Eli Lilly & Co.

[+1]

NCT06364267

/ Recruiting临床2期IIT

Randomized Double Blind Phase II Trial of Baby Exemestane vs Baby Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.

The purpose of the study is to to compare low dose of exemestane (babyexe) versus low dose of tamoxifen (babytam) in terms of change of quality of life from baseline to 12 months.

开始日期2025-10-01

申办/合作机构

Ente Ospedaliero Ospedali Galliera

[+4]

100 项与依西美坦相关的临床结果

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100 项与依西美坦相关的转化医学

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100 项与依西美坦相关的专利（医药）

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2,159

项与依西美坦相关的文献（医药）

2026-02-01·Biomaterials advances

Exploring the efficacy and mechanisms of exemestane-loaded nanoparticles in targeted breast cancer therapy

Review

作者: Goh, Khang Wen ; Wahab, Shadma ; Kesharwani, Prashant ; Sahebkar, Amirhossein ; Chauhan, Meghna ; Gupta, Garima ; Almoyad, Mohammad Ali Abdullah

Exemestane (EXE), an irreversible aromatase inhibitor, is a well-established therapeutic agent for the management of estrogen receptor-positive (ER⁺) breast cancer. Despite its proven clinical benefits, its broader therapeutic potential is limited by factors such as poor bioavailability, short plasma half-life, and undesirable off-target effects. Recent advances in nanotechnology have introduced promising strategies to address these limitations. Encapsulating EXE within nanoparticles (NPs) offers a novel platform to improve drug delivery, enhance tumor targeting, and optimize therapeutic efficacy. Various NP systems including lipid-based, polymeric, and inorganic carriers have been investigated for EXE encapsulation and delivery. These nanoformulations confer multiple advantages, such as improved solubility, sustained and controlled release, and selective delivery to malignant cells. The presented review examines the in vitro and in vivo evidence supporting the superior anticancer performance of EXE-loaded NPs, alongside their potential to overcome key challenges in breast cancer therapy. In addition, safety profiles, translational potential, and future perspectives for integrating EXE NPs into precision medicine approaches are discussed, offering insights into their application in combination with conventional treatment regimens for improved breast cancer management.

2026-01-01·STEROIDS

Microbial catalyzed derivatization of canrenone with Glomerella fusarioides, and Cunninghamella blakesleeana, and evaluation of aromatase inhibitory activity of the resulting metabolites

Article

作者: Yousuf, Sammer ; Choudhary, M. Iqbal ; Aziz, Ambreen ; Farooq, Ghulam ; Ahmed, Zaheer ; Atia-Tul-Wahab ; Shaikh, Nimra Naveed ; Choudhary, M Iqbal ; Atia-tul-Wahab ; Zafar, Humaira

The purpose of this study was to identify potential aromatase inhibitors, which might play a role in preventing breast cancer. The fungal-catalyzed microbial transformation of an anti-mineralocorticoid, canrenone (1), was catalyzed by Glomerella fusarioides, and Cunninghamella blakesleeana. Bioconversion of canrenone (1) with G. fusarioides provided a new polar metabolite 2, and two known metabolites 3 and 4, while C. blakesleana transformed compound 1 into two known polar metabolites 4, and 5. Modern spectroscopic techniques were employed to identify the structures of metabolites as 1-dehydro-11α-hydroxycanrenone (2), 1-dehydrocanrenone (3), 11α-hydroxycanrenone (4), and 11β-hydroxycanrenone (5). The SingleCrystal X-ray Diffraction (SCXRD) based structures of metabolites 2, and 3 are reported here for the first time. Canrenone (1) and the resulting metabolites 2-4 were evaluated for their human aromatase inhibitory activity. Compounds 1-4 showed the IC₅₀ values of 0.288 ± 0.0392, 0.372 ± 0.002, 0.328 ± 0.0083, and 1.102 ± 0.099, µM comparable to the standard drug, exemestane (0.26 ± 0.011 µM). All transformed products were found non-cytotoxic to human fibroblast (BJ) cell line. Furthermore, the docking studies predicted the interaction of potential inhibitors with the active site residues of the enzyme via hydrogen bonding and other non-covalent interactions. Simulation studies predicted the formation of stable enzyme-inhibitor complexes with no or insignificant perturbation during the simulation time of 100 nsec. Hence, these inhibitors may serve as preliminary hits for drug discovery against ER+ breast cancer.

2026-01-01·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Comparison of in vitro lipolysis, sequential lipolysis – ex vivo permeability, and simultaneous lipolysis - in situ perfusion for exemestane-loaded lipid-based formulations

Article

作者: Olgac, Seval ; Usta, Yilmaz ; Teksin, Zeynep Safak ; Demirel, Murside Ayse ; Timur, Burcu

This study aimed to investigate the in vitro lipolysis of five different self-nanoemulsifying drug delivery system (SNEDDS) formulations and to test the formulations by combining the in vitro lipolysis with ex vivo permeability and in situ perfusion methods as permeation steps, and then to compare the methods. Exemestane (EXE) was selected as the model drug due to its low solubility and nonionic nature. Four SNEDDS formulations, differing from the main formulation (MCF_K40) in terms of cosolvent content (MCF_CoS), oil type (LCF), digestible surfactant content (MCF_T80), and oil amount (MCF_I988), were prepared to contain equal EXE amounts and characterized. Firstly, a classical (without permeation step) in vitro lipolysis study was conducted for SNEDDS formulations and reference product. During lipolysis, higher drug precipitation, in other words, free drug fraction, was observed in formulations containing digestible excipients (MCF_T80 and MCF_I988) and reference. Subsequently, a sequential lipolysis - ex vivo permeability study was conducted for SNEDDS formulations and reference using a vertical Franz diffusion cell with porcine intestinal tissue with samples taken from lipolysis medium at different times (0., 15., and 60. min). The similar permeated EXE% and the area under the permeated EXE% - time curve values were obtained for all SNEDDS regardless of the free drug fraction. The different stages of SNEDDS lipolysis did not affect EXE permeability. Subsequently, the lipolysis study was coupled with an in situ perfusion study that would allow simultaneous lipolysis and permeation. MCF_K40 and MCF_I988, which were selected due to their differences in lipolysis extent and free drug fraction, and EXE solution were examined with this method. Despite the in vitro formulation differences, the two SNEDDS formulations showed similar effective permeability coefficient (P_eff) values to each other and those of the EXE solution. It was shown that EXE's bioavailability problem due to low solubility could be overcome with SNEDDS formulations. Furthermore, the sequential lipolysis - ex vivo permeability study was found to capture the results of the simultaneous lipolysis - in situ perfusion study, which more closely simulates in vivo. This was attributed to the use of intestinal tissue as a permeation barrier, which allowed the diffusion of colloidal-sized micelles, vesicles, and lipid digestion products in the ex vivo study. Since the in situ perfusion method is not suitable for screening of lipid-based formulations (LBF), the first data for using in vitro lipolysis combined with Franz diffusion cell with intestinal tissue instead were presented in this study. Combining lipolysis with the permeation step is necessary for the evaluation of LBF. Although both methods used in this study are promising, further evaluations are needed regarding horizontal/vertical cells, surface/volume ratio, sequential/simultaneous evaluation, and comparison with pharmacokinetic data.

199

项与依西美坦相关的新闻（医药）

2025-12-02

·Business Wire

New Data to be Presented at the 2025 SABCS Demonstrates Potential Expanded Utility of the Breast Cancer Index Test, the Leading Biomarker in Personalizing Endocrine Therapy Duration

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., today announced that 11 studies featuring the Breast Cancer Index® (BCI™) Test will be presented at the 2025 San Antonio Breast Cancer Symposium® (SABCS). Findings from these studies support the company’s ongoing commitment to help inform personalized treatment recommendations for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Building on the test’s established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy,1-7 these new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions. New Data to be Presented at the 2025 SABCS Demonstrates Potential Expanded Utility of the Breast Cancer Index Test, the Leading Biomarker in Personalizing Endocrine Therapy Duration “These data reinforce Hologic’s continued commitment to oncology innovation and advancing precision diagnostics in breast cancer care,” said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. “This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy decision-making and highlights the consistency of the BCI Test’s performance across diverse patient subgroups and sample types.” Among the new findings to be presented, one study, “Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27],” explores the BCI Test’s potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. Results from this translational analysis of the two largest landmark ovarian function suppression (OFS) trials, Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT), support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy.8^* “As we observe an increasing number of women being diagnosed with breast cancer at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life,” said primary study author Dr. Ruth O’Regan, MD. “The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects.” A full list of studies to be presented at the 2025 SABCS conference includes: Poster Session 2: December 10, 2025, 5:00pm – 6:30pm CST Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants. 9 * Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants. 9 * Poster Session 3: December 11, 2025, 12:30pm – 2pm CST Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision. 10 * Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. 8 ^* Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease. 11 * Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns. 12 * Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples. 13 * Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision. 10 * Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. 8 ^* Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease. 11 * Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns. 12 * Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples. 13 * Five additional studies featuring data on the clinical utility of the BCI Test will be presented by external investigators at 2025 SABCS, including: Poster Session 3: December 11, 2025, 12:30pm – 2pm CST Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18] 14 Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10] 15 Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19] 16 Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23] 17 Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18] 14 Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10] 15 Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19] 16 Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23] 17 Poster Session 4: December 11, 2025, 5:00pm – 6:30pm CST Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08] 18 Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08] 18 “The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test,” said Schneiders. “With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy decisions, it’s encouraging to see additional real-world and independent data reinforcing the BCI Test’s impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients.” About the Breast Cancer Index Test The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO® Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.6,7 It is the only test recognized by guidelines to predict which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.6,7 The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com. About Hologic, Inc. Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube. Forward-Looking Statements This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s and its subsidiaries’ products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based. ^Note: Incorporation of refined risk estimates in the results reported by the Breast Cancer Index test are pending appropriate regulatory approvals. For the Breast Cancer Index Intended Uses and Limitations, please visit breastcancerindex.com. *Biotheranostics, Inc. researchers are named authors in this study. Hologic, Breast Cancer Index, BCI and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks are the property of their respective owners. References Zhang Y, et al. Breast Cancer Index identifies early-stage estrogen receptor–positive breast cancer patients at risk for early- and late-distant recurrence. Clin Cancer Res. 2013;19(15):4196-4205. doi:10.1158/1078-0432.CCR-13-0804. Sgroi DC, et al. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. JNCI J Natl Cancer Inst . 2013;105(14):1036-1042. doi:10.1093/jnci/djt146. Bartlett JMS, et al. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen–To Offer More? (aTTom) trial. Ann Oncol. 2019;30(11):1776-1783. doi:10.1093/annonc/mdz289. Noordhoek I, et al. Breast Cancer Index predicts extended endocrine benefit to individualize selection of patients with HR‐positive early-stage breast cancer for 10 years of endocrine therapy. Clin Cancer Res. 2021;27(1):311-319. doi:10.1158/1078-0432.CCR-20-2737. Mamounas EP, et al. Breast Cancer Index (BCI) and prediction of benefit from extended aromatase inhibitor therapy in HR+ breast cancer: NRG Oncology/NSABP B-42. J Clin Oncol . 2021;39(15_suppl):501. doi:10.1200/JCO.2021.39.15_suppl.501 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Breast Cancer V.5.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed November 6, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Andre F, et al. J Clin Oncol. 2022;40(16):1816-1837. Referenced with permission from the American Society of Clinical Oncology (ASCO): Clinical Practice Guideline Endorsements for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer. © American Society of Clinical Oncology, 2025. All rights reserved. To view the most recent and complete version of the guideline, go online to https://ascopubs.org/guidelines [ascopubs.org]. ASCO Clinical Practice Guideline makes no warranties of any kind whatsoever regarding their content, use of application and disclaims any responsibility for their application or use in any way. O’Regan R, et al. Identifying premenopausal patients with early-stage hormone receptor–positive node-negative breast cancer at minimal risk of distant recurrence by Breast Cancer Index. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Yadav S, et al. Endocrine sensitivity and predicted benefit of extended endocrine therapy based on Breast Cancer Index (BCI) in BRCA1, BRCA2, and CHEK2 pathogenic variant carriers with ER+/HER2– breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10, 2025; San Antonio, TX. Chuy V, et al. Breast Cancer Index re-stratifies 21-gene assay risk groups for risk of recurrence and extended endocrine therapy benefit: Final analysis of the BCI Registry Study. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Chumsri S, et al. Prognostic performance of Breast Cancer Index in patients with early-stage HR+ HER2+ breast cancer treated with adjuvant trastuzumab: NCCTG N9831 (Alliance). Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Sandoval-Leon AC, et al. Comparative analysis of Breast Cancer Index testing in Hispanic and non-Hispanic populations. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Kapoor NS, et al. Comparison of Breast Cancer Index scores from core-needle biopsies versus surgical excisions in early-stage breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Tran CC, et al. Guidelines for Breast Cancer Index test before and after Epic software enhancement. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Ogunsesan Y, et al. Higher breast tumor grades could more likely benefit from extended adjuvant endocrine therapy . Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Rupani KV, et al. Correlation between Breast Cancer Index (BCI) and RSClin late in assessing 5–10-year recurrence risk in early-stage hormone receptor–positive breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Essarani M, et al. Retrospective study on Breast Cancer Index testing in a community hospital and analysis of its impact on physician decision-making for extended endocrine therapy in early breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Flood B, et al. Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood . Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. SOURCE: Hologic, Inc.

ASCO会议

2025-11-28

·腾讯网

CDK4/6i 耐药乳腺癌，国产纳米新药联合方案 DCR 为何接近 90%？| AI 对话马飞教授

2025 年圣安东尼奥乳腺癌研讨会（SABCS）将于当地时间 12 月 9 日 - 12 日在美国圣安东尼奥召开，作为全球乳腺癌领域最具影响力的学术会议之一，SABCS 汇聚了世界各地的乳腺癌权威专家学者，共同探讨乳腺癌最新临床研究进展，交流有关乳腺癌和癌前乳腺疾病各方面前沿信息，推动乳腺癌诊疗不断向精准化与个体化方向迈进。本次会议中，中国医学科学院肿瘤医院马飞教授团队开展的激素受体阳性 / 人表皮生长因子受体阴性（HR+/HER2-）晚期乳腺癌多中心 II 期临床研究入选会议壁报聚焦环节，彰显了中国学者在肿瘤领域的学术影响力。丁香园 ClinMaster 智能平台旗下全新推出「丁香智声 · SABCS 特辑」学术栏目，聚焦最新临床研究动态，围绕试验方案设计与科研成果转化展开智能解析。为提升学术内容价值，特别设置「人机互动」环节，邀请马飞教授对 AI 智能解读系统输出的内容进行精彩点评与实时互动，旨在与各位读者一同交流学习！研究内容01背景对于接受细胞周期蛋白依赖性激酶 4/6 抑制剂（CDK4/6i）治疗后出现疾病进展的 HR+/HER2- 晚期乳腺癌患者，目前临床尚缺乏标准的后续治疗方案。西罗莫司作为一种哺乳动物雷帕霉素靶蛋白（mTOR）特异性抑制剂，因其口服生物利用度较低，临床应用受到限制。将该药物与纳米白蛋白结合，形成白蛋白结合型西罗莫司（nab- 西罗莫司），则可显著提高其水溶性与生物利用度，进而提高其临床疗效。本研究旨在评估 nab-西罗莫司（HB1901）联合内分泌治疗在 CDK4/6i 治疗后进展的 HR+/HER2- 晚期乳腺癌患者中的疗效与安全性。02方法本研究为一项多中心、开放标签的 II 期临床试验，入组经病理学确诊的 HR+/HER2- 晚期乳腺癌患者，所有患者既往均接受芳香化酶抑制剂（AI）或氟维司群联合 / 不联合 CDK4/6i 治疗失败。根据既往治疗情况，研究人员将患者分为两个队列：对于既往 AI ± CDK4/6i 治疗后进展患者，给予 nab- 西罗莫司（100 mg/m²）联合氟维司群治疗（n=34）；而对于既往氟维司群 ± CDK4/6i 治疗后进展患者，则给予 nab- 西罗莫司（100 mg/m²）联合 AI 治疗（n=31）。研究的主要终点为 6 个月无进展生存（PFS）率；次要终点包括客观缓解率（ORR）、疾病控制率（DCR）、PFS 以及安全性与耐受性。同时，研究还对患者的肿瘤组织和 / 或血液样本进行了二代测序分析。03结果本研究共纳入 65 例 HR+/HER2- 晚期乳腺癌患者，患者中位年龄为 54 岁（范围 31-72 岁），其中 98.5% 的患者既往接受过内分泌治疗联合 CDK4/6i 治疗，78.5% 的患者基线存在内脏转移，50.8% 的患者既往接受过至少一种针对晚期 / 转移性疾病的化疗。截至 2025 年 5 月 31 日数据截止时，本研究中位随访时间为 9.1 个月，且仍有 15 例患者在接受研究治疗。60 例可评估疗效的患者的总体 ORR 为 20%，DCR 达 88.3%（包括 12 例部分缓解和 41 例疾病稳定的患者），中位 PFS 为 5.7 个月（95%CI：5.03–9.03），6 个月 PFS 率为 49.5%。此外，研究表明，nab- 西罗莫司联合氟维司群组（n=31）患者疗效更为突出：ORR 为 29%，DCR 达 93.5%（9 例部分缓解，20 例疾病稳定），中位 PFS 达 7.5 个月（95%CI：5.13-9.2），6 个月 PFS 率为 58.3%。基因分析显示，入组患者中共有 24 例患者（36.9%）存在 PIK3CA/AKT1/PTEN 通路相关基因突变。在联合氟维司群组中，11 例携带上述基因突变且可评估疗效患者的中位 PFS 为 9.1 个月（95%CI：3.75- 未达到），6 个月 PFS 率为 70.1%，ORR 为 27.3%，DCR 达 100%。值得注意的是，该药物在 20 例 PIK3CA/AKT1/PTEN 野生型患者中也表现出了令人鼓舞的疗效：ORR 为 30%，DCR 达 90%，中位 PFS 为 7.4 个月（95%CI：4.4-9.2），6 个月 PFS 率为 52.6%。安全性方面，总体患者治疗相关不良事件（TRAE）发生率为 98.5%（64/65），多数为 1-2 级。最常见的 TRAE 包括高甘油三酯血症（61.5%）、高胆固醇血症（60%）和低钾血症（60%）。26 例患者（40.0%）出现 ≥ 3 级 TRAE，其中低钾血症（16.9%）和高甘油三酯血症（10.8%）的发生率超过 5%。此外，研究中未发生导致死亡的药物相关事件，仅 1 例患者因不良事件永久停药。04结论研究结果显示，nab- 西罗莫司具有良好的抗肿瘤活性，且安全性可控，尤其与氟维司群联合用药时 ORR 达 29%，中位 PFS 达 7.5 个月，DCR 达 93.5%，提示这种基于新型 mTOR 抑制剂的联合内分泌治疗方案有望为 CDK4/6i 治疗后进展的 HR+/HER2- 晚期乳腺癌患者带来新的治疗选择。ClinMaster 解读结果及临床价值01核心数据结果疗效优势：nab- 西罗莫司联合氟维司群组中位 PFS 达 7.5 个月，ORR 为 29%，DCR 达 93.5%，疗效显著改善。为难治人群提供新选择：内脏转移、经过 CDK4/6i 和化疗等多线治疗后进展的患者，临床选择较为有限且疗效常不理想。该研究证实 nab- 西罗莫司联合方案能为此类患者带来具有临床意义的疾病控制。打破基因限制：在传统上不敏感的 PIK3CA 野生型患者中，同样观察到 30% 的 ORR 与 7.4 个月的中位 PFS，打破既往疗法的基因型限制。02临床价值提供临床新方案：为 CDK4/6i 治疗后进展的难治性 HR+/HER2- 晚期乳腺癌提供了兼具高效与便捷的联合治疗新选择。潜在普适疗法：该方案在 PIK3CA/AKT1/PTEN 突变及野生型患者中均展现出良好疗效，有望使其成为无需等待基因检测结果的「通用型」优选方案。验证技术突破：白蛋白纳米技术成功将常见药物西罗莫司转化为「高效新药」，为药物研发开辟了新路径。马飞教授解答 AI 提问Q1本研究结果显示，「nab- 西罗莫司 + 氟维司群」方案显示出了更优的抗肿瘤疗效，您认为这背后潜在的生物学机制是什么？马飞教授：「nab- 西罗莫司 + 氟维司群」联合方案的疗效优势可能源于其对内分泌治疗及 CDK4/6i 耐药机制的双重抑制。一方面，PAM 信号通路（PI3K/AKT/mTOR）的过度激活是乳腺癌内分泌治疗耐药的重要机制之一。临床前研究显示，PI3K 与 AKT 可磷酸化 ERα 的 Ser167 位点，从而在缺乏雌激素的情况下仍激活 ERα，导致肿瘤细胞对内分泌治疗不敏感。因此，抑制 PI3K/AKT/mTOR 通路有助于恢复肿瘤对内分泌治疗的敏感性。另一方面，该通路也与 CDK4/6i 耐药相关。长期使用 CDK4/6i 可导致 PI3K/mTOR 通路上调，进而促进细胞周期蛋白 D（Cyclin D）表达，推动细胞周期进展，从而削弱 CDK4/6i 的疗效。因此，nab- 西罗莫司作为 mTOR 抑制剂，联合氟维司群可协同阻断上述耐药路径，提升治疗效果，为 CDK4/6i 经治失败的 HR+/HER2- 晚期乳腺癌患者提供潜在的治疗选择。Q2研究在 PIK3CA/AKT1/PTEN 野生型患者中也观察到了卓越的疗效，这似乎挑战了相关靶点抑制剂需依赖 PIK3CA/AKT1/PTEN 通路突变的传统认知。您认为 nab- 西罗莫司是通过何种机制克服了这一限制，从而实现「全人群」获益？马飞教授：mTOR 作为 PI3K/AKT 通路的核心下游效应分子，在整合多种上游信号及调控细胞合成代谢中发挥了枢纽作用。其激活不仅受 PIK3CA/AKT1/PTEN 等基因突变影响，还可通过 TSC1/2 等其他上游调控因子实现。因此，抑制 mTOR 相当于在信号通路中设置「总闸」，可阻断由不同机制驱动的肿瘤生长信号。相较于仅针对特定节点的 PI3K 或 AKT 抑制剂，mTOR 抑制剂具有更广泛的抑制作用，能够覆盖更多信号旁路或替代激活途径，从而在包括野生型在内的不同分子亚型中均可能发挥疗效，实现更广泛的治疗获益。Q3考虑到该方案的疗效前景及良好的耐受性，您如何看待未来其在 CDK4/6i 治疗后进展患者中的后续治疗定位？团队是否有计划开展与当前标准治疗（如阿贝西利 + 氟维司群，或依维莫司 + 依西美坦）头对头比较的 III 期临床研究以明确其疗效？马飞教授：该方案作为国内开展的完全针对 CDK4/6i 治疗失败的 HR+/HER2- 晚期乳腺癌患者的临床研究，为 mTOR 抑制剂逆转内分泌治疗耐药及 CDK4/6i 耐药后的治疗策略提供了有力的循证依据。其优势在于可在化疗前为患者提供有效且耐受性良好的靶向治疗选择，有助于延长患者的生存时间并改善生活质量。目前，全国范围内已启动关键 III 期临床研究，旨在比较 nab- 西罗莫司联合氟维司群与氟维司群单药的疗效。此外，随着口服选择性雌激素受体降解剂在克服内分泌耐药方面的潜力日益凸显，未来也计划开展该联合方案与依维莫司联合依西美坦的头对头 III 期试验，进一步明确其在标准治疗序列中的优势与定位。专家简介马飞教授中国医学科学院肿瘤医院主任医师、教授、博士生导师、长江学者特聘教授国家癌症中心 / 中国医学科学院肿瘤医院内科治疗中心主任国家抗肿瘤药物临床应用监测专委会秘书长国家肿瘤质控中心乳腺癌专委会副主委国家癌症中心乳腺癌筛查与早诊早治规范委员会秘书长健康中国行动推进委员会入库专家中国药师协会肿瘤专科药师分会副主委中国抗癌协会整合肿瘤心脏病分会副主委中国抗癌协会多原发和不明原发肿瘤专委会副主委中国抗癌协会肿瘤药物临床研究专委会秘书长全国女性卵巢保护与抗衰促进工程专委会副主委中国老年学和老年医学学会老年肿瘤分会总干事长北京乳腺病防治学会副理事长北京市肿瘤治疗质量控制和改进中心肿瘤化疗质控专委会主委Cancer Innovation 主编获得国家科技进步奖二等奖，及「首都十大杰出青年医生」、「中国肿瘤青年科学家奖」等荣誉称号审校：马飞教授题图：丁香园团队

临床2期临床结果

2025-11-25

·法迈医讯

探谈|生存分析在FDA审核过程中面临的挑战

在医药研发的浩瀚征途中，生存分析作为评估药物疗效与安全性不可或缺的一环，其重要性不言而喻。然而，当这一科学工具踏入FDA（美国食品药品监督管理局）严格的审核门槛时，便不可避免地遭遇了诸多挑战。FDA，作为全球医药监管的标杆，以其严谨的标准、详尽的审查流程以及对患者福祉的深切关怀，对每一份提交的数据都进行了近乎苛刻的审视。生存分析，作为连接临床试验数据与药物上市决策之间的桥梁，其结果的准确性、可靠性以及是否符合FDA的期望，直接关系到药物能否顺利获得批准，进而惠及广大患者。因此，在FDA的审核过程中，生存分析不仅要面对数据收集、处理与分析的复杂性，还要面临假设的适用性以及对不同亚组患者的敏感性分析等多个层面的考验。面对这些挑战，医药研发领域的专业人士不仅需要具备深厚的专业知识，还必须掌握应对FDA审核要求的策略与技巧。因此，深入理解生存分析在FDA审核中的实际应用与注意事项，成为了提升研发效率、加速药物上市的关键。为了助力这一目标的实现，我们精心设计了生存分析系统课程，旨在全面解析生存分析在FDA审核中的挑战与应对之道，同时传授实用的数据分析方法与策略，帮助学员在医药研发的征途上更加从容不迫。接下来，就让我们一同走进这期课程，探索生存分析的奥秘。推荐指南该指南中对于如何处理删失数据给出了详细的介绍和指导意见。授课案例 EMERALD研究：一项多中心、随机、开放标签、随机对照的III期临床试验，纳入478例患有ER阳性、HER2阴性晚期或转移性乳腺癌的绝经后女性和男性，其中228例患者具有ESR1突变。患者被随机分配（1:1）接受口服Elacestrant 345mg，每日一次（n=239）或研究者选择的内分泌治疗(SOC组，n=239)，其中包括氟维司群(n=166)或芳香化酶抑制剂(n=73)，芳香化酶抑制剂包括阿那曲唑、来曲唑、依西美坦。主要终点： PFS（BICR评估；所有患者、ESR1-mut患者）。关键次要终点： OS（所有患者、ESR1-mut患者）。其他次要终点： PFS和OS（BICR评估；ESR1-mut患者）；PFS（研究者评估）；客观缓解率；缓解持续时间和临床获益率（BICR评估和研究者评估）；安全性；耐药性。分层因素： ESR1突变状态（检测到与未检测到）既往使用氟维司群治疗（是与否）内脏转移（是与否）研究结果：存在ESR1突变的患者：Elacestrant显著改善了该亚组患者的PFS，危险比(HR)为0.55 (95% CI 0.39-0.77)，中位PFS为3.8个月，而SOC为1.9个月。总生存期(OS)趋势：该亚组患者的OS没有显著改善，但也没有发现潜在的损害趋势，HR为0.90 (95% CI 0.63-1.30)。所有患者(意向治疗人群)：Elacestrant也显著改善了所有患者的PFS，HR为0.70 (95% CI 0.55-0.88)，但主要归因于存在ESR1突变的患者。无ESR1突变的患者：Elacestrant在该亚组患者的PFS改善较小，HR为0.86 (95% CI 0.63-1.19)，中位PFS为1.9个月，而SOC为2.0个月。总体响应率：Elacestrant和SOC的总体响应率较低，存在ESR1突变的患者中Elacestrant略高。 2022年6月，Stemline公司向FDA提交了Elacestrant（依拉司群、艾拉司群）的三期临床研究数据，以期该药物获得全人群的上市批准: 2023年1月27日，美国食品药品管理局（FDA）基于该III期的临床试验结果，仅批准Elacestrant用于既往接受过至少一线内分泌治疗后疾病进展的ER+、HER2-、ESR1突变的绝经后女性或成年男性晚期或转移性乳腺癌患者：在FDA的评审意见中，我们看到了FDA细致入微的分析与举证，给出了仅对ERS1突变的特定亚组人群批准而非全人群批准的科学依据与审慎考量。 FDA观点：ITT人群的治疗效果主要由ESR1突变亚群驱动：证据1：通过分析发现，针对没有ESR1突变的患者，Elacestrant对比SOC，两者的疗效差异没有统计学意义：证据2：FDA提供了针对没有ESR1突变的患者，Elacestrant与SOC相比，KM生存曲线图中显示的两者结果也没有统计学差异：证据3：FDA怀疑存在违反比例风险假设，从而影响Cox模型的结果。因此，进一步采用了受限平均生存时间（RMST）分析，结果显示：在未携带ESR1突变的亚组中，Elacestrant与SOC相比，其结果同样未发现统计学差异： RMST分析与KM图在生存分析中各有其独特的价值和应用场景，罗晟教授在课程中解释了RMST的定义、计算方法和统计性质：证据4. FDA观察到PFS的评估在独立影像评估（IRC）与研究者评估（INV）之间存在较大偏倚，并且鉴于这是一个开放性临床试验，这种偏移的可能性被进一步放大，更加坚定了FDA认为评估结果可能受到影响的看法：如何理解FDA评估的“High Discordance Rate”？FDA提供了哪些证据来支持这一观点？听听罗教授的讲解: 以下视频来源于国际临研AOCRAS 以上内容都摘自《生存分析实操训练营》的模块一，罗教授通过FDA的评审文件，指导学员们深入理解FDA评估框架，解释这些评估点之间的内在联系，抽丝剥茧，通过案例中每一个被FDA挑战的点深度剖析，总结失败的原因和教训，小编认为此评审文件堪称“生存分析避坑指南”。课程内容 1. 理解生存分析的基本概念 2. 掌握删失数据的定义、分类 3. 造成删失的原因有哪些 4. 处理删失数据的重要性 5. 处理删失数据的常见方法 6. KM生存曲线图的绘制原理 7. 如何通过KM图识别关键信息 8. 两组删失比例的差别对生存分析的影响 9. 如何提高生存分析结果的准确性和可靠性 10.解读FDA对处理删失数据的指导意见《生存分析实操训练营》试听课试听视频线上课程+理论与实操+专属学习群录播课程，可随时随地学，无限次收听报名咨询请扫描微信二维码添加阿宅老师备注 “ 临研课程 ” 欢迎加入1421+人的中国临床试验千人通讯录精品课程推荐国际临床研究系列课程十套课已全部更新完毕！现购课福利多多！一期和二三期临床试验设计实操训练营多终点设计实操训练营联合用药研究设计实操训练营 ADC临床试验设计实操训练营 Protocol撰写实操训练营期中分析设计实操训练营生存分析实操训练营《AI赋能Protocol撰写Workshop》训练AI按要求帮你完成专业的protocol撰写,附课程试听！统计师必看：从实际案例系统学习临床试验前沿设计方法好课推荐| 生物统计学方法讲解与应用系列培训课程好课推荐|SAS程序员统计编程技能系列录播课程推荐|临床试验标准化提交辅导系列培训统计程序员TFLs编程系列录播课程，42节课程干货满满！学习|SAS 绘图系列课程！！！生翼计划:临床SAS程序员实战项目训练营开营啦！真实临床试验项目数据练手,模拟工作环境,体验工作日常！推荐|药物警戒系列课程模块一二三四好课推荐|CRA系列课程好课推荐|临床试验数据管理系列录播课程推荐|CRA能力提升系列培训课程药物警戒体系全套SOPs：符合国家局核查标准！符合B证现场检查！关于举办“2025定量药理学建模与模拟基础（NONMEM软件）培训班”的通知 21节SAS初级编程系列课程在线免费观看【重磅推出】FDA483报告与警告信典型案例解读系列课程推荐|AI撰写Protocol训练营详细课表更新-学员反馈很棒的活动！精品资料包推荐真实世界研究全套资料包！临床试验贝叶斯设计资料包：17本书籍+14篇文献干货满满！ FDA药物警戒资料包领取|临床研究统计方法必看的15本知名书籍！领取| 临床SAS编程和数据管理全套干货资料包！药物警戒全套精华资料包收藏|知名书籍：临床试验的贝叶斯自适应方法法规|ICH-GCP中英文对照（最完整版）收藏|E9：临床试验统计原则（另附中英文对照词汇表）免费公开课|21节SAS Base初级编程系列课程限时领取|杜克临床研究所的临床试验手册汇总|临床试验十七个相关知识点免费领取|临床研究几本经典书籍！最全汇总：Define-XML 2.1指导原则讲解视频分享|专属生物统计师的几本经典书籍汇总|电子版CDISC-SDTM基本理论及实践系列文章限时领取|8.72G临床试验精华资料包(共180个文件）送给临研人的福利！限时领取|符合国际标准的全套临床SOP资料包,651个文件供你参考学习！汇总帖：CDISC标准干货文章和资料精选汇总帖：生物统计系列干货文章和资料精选汇总帖：SDTM干货文章和资料精选免费领取|ADC(抗体药物偶联物)知名书籍：研发,临床,注册及市场发展领取|生物等效性试验（BE试验）比较全面的知名书籍！汇总|CDE ICH指导原则全系列培训视频必看|学习生物制药CMC必看的23本书籍！限时免费|书籍: 临床数据管理实用指南第三版收藏|抗肿瘤药物创新研发必看16本书籍！福利|专属CRC的全套资料包免费领取收藏|547页CDASHIG v2.3 FINAL 领取知名书籍:新临床试验人员的基本概念&药物开发中的定量决策汇总|生物统计系列十五篇干货文章！收藏|临床研究设计与方案撰写资料包！！汇总|生物统计系列十五篇干货文章！汇总|生物统计学常用统计分析方法系列文章汇总|SAS编程应用及相关知识分享系列文章收藏|药物临床试验必备文件及相关管理要求限时领取|CRA应看的5本知名书籍！ >>>> 公众号推荐欢迎关注法迈新媒体更多，更及时的干货内容，请加我们的微信公众号：法迈医讯，诚邀业内人士及机构向我们投稿。投稿邮箱：bellama@pharmanews.cn 【免责声明】文章为网络整理，不代表“法迈医讯”立场。如因作品内容、版权等存在问题，请于本文刊发30日内联系法迈医讯进行删除或洽谈版权使用事宜。法迈医讯作为法迈新媒体微信公众号矩阵之一，法迈新媒体是国内一家面向制药行业供应链综合服务平台，致力于服务全球制药行业从业人员。以创新的互网+模式服务于行业用户，形成以“资源整合，知识共享”为核心，微信公众号矩阵、社群矩阵为分支的新媒体模式，力争打造国内活跃和具影响力的专业化平台！

100 项与依西美坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00963	依西美坦	L02BG06	DB00990

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
ER阳性乳腺癌	美国	Pfizer Inc.	1999-10-21
乳腺癌	瑞士	Pfizer Inc.	1999-10-14

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	申请上市	中国	Cipla Ltd.	2022-05-13
肿瘤	申请上市	中国	泊诺（天津）创新医药研究有限公司	2022-05-13
绝经前乳腺癌	临床3期	中国	Pfizer Inc.	2018-08-09
HR阳性/HER2阴性乳腺癌	临床3期	奥地利	Pfizer Inc.	2014-03-13
HR阳性/HER2阴性乳腺癌	临床3期	奥地利	AstraZeneca PLC	2014-03-13
HR阳性/HER2阴性乳腺癌	临床3期	匈牙利	Pfizer Inc.	2014-03-13
HR阳性/HER2阴性乳腺癌	临床3期	匈牙利	AstraZeneca PLC	2014-03-13
HR阳性/HER2阴性乳腺癌	临床3期	以色列	AstraZeneca PLC	2014-03-13
HR阳性/HER2阴性乳腺癌	临床3期	以色列	Pfizer Inc.	2014-03-13
HR阳性/HER2阴性乳腺癌	临床3期	西班牙	AstraZeneca PLC	2014-03-13

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04272801 (POWER, CTgov)	临床2期	早期乳腺癌	84	Patient reported outcomes+letrozole+tamoxifen+exemestane+anastrozole	鑰鹽獵願壓鑰範蓋憲衊 = 鑰範醖選鑰壓膚鬱顧繭襯遞製範襯憲壓選鹹繭 (築製範齋繭遞憲願獵構, 遞夢蓋築壓窪鏇選簾餘 ~ 顧遞窪齋獵築簾蓋壓製) 更多	-	2025-10-22
NCT00253422 (SoFEA, CTgov)	临床3期	乳腺癌	698	fulvestrant+anastrozole (Faslodex + Placebo)	願鹹淵鑰繭衊糧廠齋憲(齋壓積蓋艱構齋糧餘膚) = 獵壓顧製衊窪艱顧鏇鬱繭鏇襯觸積顧簾製製積 (蓋鑰膚蓋膚窪繭獵製膚, 襯糧襯窪遞獵窪齋衊網 ~ 蓋選襯鹹鬱鏇襯糧構艱) 更多	-	2025-06-04
				fulvestrant+anastrozole (Faslodex + Arimidex)	願鹹淵鑰繭衊糧廠齋憲(齋壓積蓋艱構齋糧餘膚) = 鹹製膚構夢襯積網鹽鏇繭鏇襯觸積顧簾製製積 (蓋鑰膚蓋膚窪繭獵製膚, 遞觸襯鹽窪鬱選鑰衊遞 ~ 顧願鹹壓壓壓糧蓋艱衊) 更多
NCT03300557 (CTgov)	临床2期	子宫内膜样上皮内瘤变 \| 子宫内膜样腺癌 \| 子宫内膜增生 ... 更多	40	Pharmacokinetic Study+Exemestane	鹽糧顧製廠廠繭艱憲憲(顧鏇壓餘鬱繭鑰糧顧鹽) = 廠簾築願築餘遞顧鹽鏇網遞築鑰餘鏇遞餘衊膚 (鹹繭觸衊壓鹹鹽膚壓壓, 0.22) 更多	-	2025-06-03
SOFT and TEXT (ASCO2025)	N/A	HR阳性乳腺癌辅助 hormone receptor-positive	-	Exemestane + Ovarian Function Suppression	鹽壓構糧積製獵鬱淵積(構構襯醖夢憲選齋衊觸) = 襯顧廠獵願夢願繭齋憲鬱鬱淵衊簾鹹觸壓鏇構 (醖獵淵餘顧製築鏇蓋積 ) 更多	积极	2025-05-30
				Tamoxifen + Ovarian Function Suppression	鹽壓構糧積製獵鬱淵積(構構襯醖夢憲選齋衊觸) = 襯艱網蓋選窪獵製糧遞鬱鬱淵衊簾鹹觸壓鏇構 (醖獵淵餘顧製築鏇蓋積 ) 更多
NCT02990845 (Pubmed) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 ER Positive \| HER2 Negative	15	Pembrolizumab + exemestane + leuprolide	齋遞餘網衊夢獵選築糧(網廠鬱壓簾憲製鏇積築) = 鏇衊壓艱蓋繭鹹鏇夢蓋積艱齋選衊遞夢顧鹹廠 (襯鑰遞簾構鬱醖觸衊淵 ) 更多	积极	2024-12-18
NCT02028507 (PEARL \| GEICAM/2013-02 PEARL \| PEARL study, CTgov)	临床3期	转移性乳腺癌 \| HR阳性/HER2阴性乳腺癌	693	palbociclib+Exemestane (Cohort 1: Palbociclib Plus Exemestane)	遞齋鏇壓觸艱憲繭鹹選(襯構觸鹽醖糧鑰鑰築選) = 憲網網衊淵築觸簾壓餘願獵網繭鹹積範鏇艱構 (選願廠願顧構鏇齋觸廠, 鹽選膚壓鹽廠繭齋築餘 ~ 製鬱糧網築鑰顧衊膚鹽) 更多	-	2024-09-25
				fulvestrant+palbociclib (Cohort 2: Palbociclib Plus Fulvestrant)	遞齋鏇壓觸艱憲繭鹹選(襯構觸鹽醖糧鑰鑰築選) = 鏇鹹構鏇夢鹹廠顧願餘願獵網繭鹹積範鏇艱構 (選願廠願顧構鏇齋觸廠, 淵繭觸鹹鹽淵範齋壓醖 ~ 憲選觸糧簾獵選構獵餘) 更多
NCT06009627 (ESMO2024) 人工标引	临床2期	绝经前乳腺癌新辅助 HER2 Negative \| HR Positive	32	Dalpiciclib, Exemestane, and Goserelin	夢廠繭範醖餘顧築衊醖(獵憲鏇醖醖窪襯鬱簾構) = 遞製簾簾夢選齋顧艱夢餘鹽蓋遞憲膚夢鹽網築 (醖鹹醖鹽憲餘壓憲積願 )	积极	2024-09-16
				TAC (docetaxel, doxorubicin, and cyclophosphamide)	夢廠繭範醖餘顧築衊醖(獵憲鏇醖醖窪襯鬱簾構) = 構衊製構蓋醖糧網餘壓餘鹽蓋遞憲膚夢鹽網築 (醖鹹醖鹽憲餘壓憲積願 )
NCT03312738 (BOLERO-5, Pubmed) 人工标引	临床2期	ER阳性/HER2阴性乳腺癌 HER2 Negative \| ER Positive	159	Everolimus (EVE) + Exemestane (EXE)	顧觸夢範鬱構範願憲獵(遞範遞願淵範鏇觸廠範) = 夢選淵鑰壓築蓋鑰觸繭願範鏇鹹鏇淵糧構築簾 (艱襯夢窪艱鬱艱鬱夢鑰, 5.5 ~ 9.0)	积极	2024-06-21
				Placebo (PBO) + Exemestane (EXE)	顧觸夢範鬱構範願憲獵(遞範遞願淵範鏇觸廠範) = 衊窪鏇築築憲窪遞餘廠願範鏇鹹鏇淵糧構築簾 (艱襯夢窪艱鬱艱鬱夢鑰, 1.9 ~ 3.6)
NCT01594216 (CTgov)	临床2期	ER阳性乳腺癌	25	Ruxolitinib+Exemestane (First Stage)	積願繭願醖顧齋壓鏇鬱 = 構膚範窪鏇製簾範積獵艱鹽鑰鏇簾襯遞鏇鬱齋 (齋積鑰餘衊齋繭願獵憲, 廠顧醖壓顧醖簾窪鬱遞 ~ 鹹糧構夢鏇齋鑰醖鑰鏇) 更多	-	2024-06-12
				Ruxolitinib+Exemestane (Second Stage)	積願繭願醖顧齋壓鏇鬱 = 鏇鏇鬱積網遞齋願鏇鹹艱鹽鑰鏇簾襯遞鏇鬱齋 (齋積鑰餘衊齋繭願獵憲, 鏇繭憲壓鏇膚獵艱憲衊 ~ 製鹽鬱窪簾憲餘選簾鹽) 更多
ASCO2024	N/A	绝经期综合征	128	Anastrozole/Letrozole	醖蓋壓憲遞壓簾醖構鹽(繭構蓋觸艱顧淵選繭醖) = 憲糧網蓋餘齋廠廠窪淵遞製齋選膚觸鹹網鏇餘 (糧糧齋廠顧築鑰憲淵齋 ) 更多	积极	2024-05-24
				Exemestane	醖蓋壓憲遞壓簾醖構鹽(繭構蓋觸艱顧淵選繭醖) = 夢鏇鬱觸鹹餘糧壓鑰獵遞製齋選膚觸鹹網鏇餘 (糧糧齋廠顧築鑰憲淵齋 )