Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy in Early-stage HR-positive/HER2-negative Breast Cancer: a Multicenter, Prospective Clinical Study

This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.
The primary endpoint is 3-year invasive disease-free survival (iDFS).

开始日期2025-09-01

申办/合作机构

福建省肿瘤医院（福建省肿瘤研究所、福建省癌症防治中心）

NCT07037199

/ Not yet recruiting临床2期IIT

The Efficacy and Safety of SHR-A1811 Sequential Dalpiciclib Combined With Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer

This multicenter, prospective phase II clinical trial evaluates the efficacy and safety of sequential SHR-A1811 followed by dalpiciclib plus endocrine therapy (fulvestrant or aromatase inhibitors) in 45 patients with HR+/HER2-low/ultra-low advanced breast cancer. Enrolled patients will receive SHR-A1811 monotherapy for 6-8 cycles until clinical benefit, then transition to dalpiciclib with endocrine therapy until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), overall survival (OS), and treatment-related adverse events (TRAEs). The study will be conducted at Sun Yat-sen Memorial Hospital and collaborating centers.

开始日期2025-06-20

申办/合作机构

中山大学孙逸仙纪念医院

NCT06810492

/ Not yet recruitingN/AIIT

A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

开始日期2025-04-01

申办/合作机构

湖北省肿瘤医院（湖北省肿瘤研究所）

100 项与羟乙磺酸达尔西利相关的临床结果

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100 项与羟乙磺酸达尔西利相关的转化医学

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100 项与羟乙磺酸达尔西利相关的专利（医药）

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项与羟乙磺酸达尔西利相关的文献（医药）

2025-04-01·Cancer Communications

A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+/HER2‐ breast cancer‐FINEST study

Article

作者: Liu, Guang‐Yu ; Li, Jun‐Jie ; Wu, Wen‐Ya ; Liang, Fei ; Wu, Jiong ; Chen, Li ; Yu, Ke‐Da ; Wang, Zhong‐Hua ; Di, Gen‐Hong ; Shao, Zhi‐Ming ; Fan, Lei

Abstract:

Background:

Hormone receptor‐positive (HR+)/humaal growth factor receptor 2‐negative (HER2‐) breast cancer, the most common breast cancer type, has variable prognosis and high recurrence risk. Neoadjuvant therapy is recommended for median‐high risk HR+/HER2‐ patients. This phase II, single‐arm, prospective study aimed to explore appropriate neoadjuvant treatment strategies for HR+/HER2‐ breast cancer patients.

Methods:

Eligible female patients with newly diagnosed, untreated HR+/HER2‐ breast cancer received 2 cycles of nab‐paclitaxel and carboplatin (nabPCb). Magnetic resonance imaging (MRI) was performed to assess tumor responses, and 40% regression of the maximal tumor diameter was deemed chemo‐sensitive. Chemo‐sensitive patients continued nabPCb for 4 more cycles (group A). Chemo‐insensitive patients were randomized to groups B, C, and D at a ratio of 1:3:1 to receive a new chemotherapy for 4 cycles or endocrine‐immune‐based therapy (dalpiciclib, letrozole and adebrelimab, with goserelin if patients were premenopausal) for 4 cycles or to undergo surgery. Peripheral blood and core‐needle biopsy (CNB) samples were collected before treatment, followed by a next‐generation sequencing (NGS) panel detection and similarity network fusion (SNF) typing through digital pathology data. The primary endpoint was the pathological complete response (pCR) rate, and the secondary endpoint was the clinical objective response rate (ORR).

Results:

A total of 121 patients were enrolled (67.8% with stage III disease), with 76, 9, 27, and 9 patients in groups A, B, C and D, respectively. The total pCR rate was 4.1%, and all patients who received pCR were in group A. Group C had a better ORR than Group B (81.5% vs. 66.7%). Exploratory analysis revealed that patients with the SNF4 subtype were the most sensitive to nabPCb (pCR rate of 21.1% vs. 1.8% in group A), whereas patients in group C with the SNF2 subtype were more sensitive to endocrine‐immune‐based therapy (Miller‐Payne grade 4‐5, 45.5% vs. 6.3%).

Conclusions:

Converting to endocrine‐immune‐based therapy improved the ORR, but not the pCR rate in chemo‐insensitive patients. Neoadjuvant chemotherapy and endocrine therapy are not mutually exclusive. The SNF4 subtype of HR+/HER2‐ breast cancer was more chemo‐sensitive, whereas the SNF2 subtype might be more sensitive to immunotherapy.

2025-02-01·BREAST

Influence of ethnicity on cyclin-dependent kinase inhibitor efficacy and toxicity: A systematic review and meta-analysis

Review

作者: De Santis, Pierluigi ; Pagliuca, Martina ; Arpino, Grazia ; De Laurentiis, Michelino ; Giuliano, Mario ; De Angelis, Carmine ; Pavone, Giuliana ; Longobardi, Alessandra ; Caputo, Roberta ; Caltavituro, Aldo ; Del Mastro, Lucia ; Puglisi, Fabio ; Tafuro, Margherita ; Buonaiuto, Roberto

BACKGROUND:

The combination of cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) with endocrine therapy (ET) is the standard of care for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (aBC). While the efficacy and safety profiles of CDK4/6i and ET have been extensively evaluated in phase II and III trials worldwide, it remains unclear whether the response to CDK4/6i and toxicity profile vary among Asian and non-Asian patients. Therefore, we aimed to assess the treatment efficacy of ET with and without CDK4/6i by comparing outcomes in Asian and non-Asian subgroups included in these clinical trials. In addition, we evaluated the toxicity profiles of the treatments by estimating the risk of treatment-related adverse events (AEs).

METHODS:

We conducted a meta-analysis including the most recent randomized trial data systematically searched from PubMed, Embase, Web of Science, Cochrane CENTRAL (from inception to May 31st, 2024) or presented in abstracts or oral presentations at the ESMO, ASCO, and SABCS international congresses. We included studies comparing CDK4/6i (palbociclib, ribociclib, abemaciclib, dalpiciclib) + ET versus placebo + ET. Progression-free survival (PFS) and overall survival (OS), hazard ratios (HR), and 95 % confidence intervals (CI) were extracted for the two subgroups of interest. To evaluate the treatment-related toxicity profiles, we extracted the number of side effects to estimate the risk of treatment-emergent AEs.

RESULTS:

Eleven studies (n = 5129) were included in this meta-analysis. The addition of CDK4/6i to ET consistently improved PFS in both Asian (HR = 0.52, 95 % CI 0.47-0.60; p < 0.001) and non-Asian (HR = 0.58, 95 % CI 0.52-0.64; p < 0.001) groups. Similarly, the combination of CDK4/6i + ET led to an OS improvement in both Asian (HR = 0.75, 95 % CI 0.62-0.91; p = 0.003) and non-Asian (HR = 0.81, 95 % CI 0.73-0.89; p < 0.001) patients. The risk of treatment related toxicity was higher in the CDK4/6i + ET arm in both Asian and non-Asian groups. Interestingly, a numerically higher rate of treatment-related hematological toxicity was observed in Asian patients, although no significant interethnic difference was found in the relative risk of these events.

CONCLUSIONS:

The combination of CDK4/6i and ET significantly improves PFS and OS compared to ET alone in both Asian and non-Asian patients with HR+/HER2-aBC. Although the magnitude of benefit appears to be independent of ethnicity, future clinical trials should devise a standardized method for stratifying patients by ethnicity to more effectively assess potential differences in treatment benefits.

SYSTEMATIC REVIEW REGISTRATION:

PROSPERO registration number: CRD42024543217.

2025-01-23·JOURNAL OF MEDICINAL CHEMISTRY

Elucidating Binding Selectivity in Cyclin-Dependent Kinases 4, 6, and 9: Development of Highly Potent and Selective CDK4/9 Inhibitors

Article

作者: Xing, Yajie ; Cao, Qixiong ; Chen, Jiean ; Wang, Rui ; Yang, Qianqian ; Pan, Shuqiong ; Feng, Meixi ; He, Zhipeng ; Huang, Yong ; Lian, Chenshan ; Jiang, Chenran ; Kang, Wei ; Yang, Jinglei ; Liu, Zhihong ; Yin, Feng ; Wu, Yun-Dong ; Ye, Yuxin ; Song, Chunli ; Zhao, Juan

CDK4/6 inhibitors are effective in treating HR⁺/HER2^- breast cancer but face limitations due to therapeutic resistance and hematological toxicity, particularly from strong CDK6 inhibition. To address these challenges, designing selective inhibitors targeting specific cyclin-dependent kinases (CDK) members could offer clinical advantages and broaden CDK inhibitor indications. However, the highly conserved binding pockets of CDKs complicate selective targeting. This study leverages in silico modeling and structural analysis of cocrystal data to identify subtle differences in key CDK binding pockets. Notably, a sequence difference in the αD-helix motif between CDK4 and CDK6 provides a targetable "sweet spot" for selectivity. By incorporating a 1,4-trans-cyclohexanediamine side chain, we designed molecules that favor interactions with CDK4 over CDK6 and explored potential dual CDK4/9 inhibition. This approach yielded a lead compound with distinct in vitro selectivity and promising in vivo pharmacokinetics, offering valuable insights for the development of selective next-generation CDK inhibitors.

311

项与羟乙磺酸达尔西利相关的新闻（医药）

2025-08-01

·ioncology

JAMA Oncol发表胡夕春/王树森教授领衔开展的TIFFANY研究成果

点击蓝字，关注我们激素受体阳性HER2阴性乳腺癌大约占全部病例的70%，内分泌治疗是这些患者的标准治疗方案，但是大多数患者最终对内分泌治疗耐药，细胞周期蛋白依赖性激酶CDK4和CDK6过度活跃是内分泌治疗耐药的主要原因之一。对于激素受体阳性HER2阴性晚期乳腺癌内分泌治疗耐药患者，PALOMA-3、MONALEESA-3、MONARCH 2、DAWNA-1研究已经证实：CDK4/6抑制剂哌柏西利、瑞波西利、阿贝西利、达尔西利联合氟维司群与单用氟维司群相比，进展或死亡风险分别降低58%、43%、45%、58%。2025年6月，复旦大学附属肿瘤医院胡夕春和张剑等学者发表一期临床研究结果证实，中国原研CDK4/6抑制剂泰瑞西利联合氟维司群治疗激素受体阳性HER2阴性晚期乳腺癌内分泌治疗耐药患者客观缓解率达53.8%、中位无进展生存达17.0个月。一期临床研究之后，该药物直接进入三期临床研究的探索，由胡夕春教授和王树森教授牵头开展。BTP-66711 (NCT03791112): A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor2025年7月31日，《美国医学会杂志》肿瘤学分册在线发表复旦大学附属肿瘤医院陶中华①、张剑①、胡夕春✉️、中山大学肿瘤防治中心郑秋帆①、王树森✉️、山东第一医科大学附属肿瘤医院王永胜、哈尔滨医科大学附属肿瘤医院蔡莉、威海市立医院徐红燕、宜昌市中心人民医院许新华、邢台市人民医院孔祥顺、永州市中心医院丁思娟、天津市肿瘤医院郝春芳、四川省肿瘤医院王浩、郑州大学第一附属医院宗红、蚌埠医科大学第一附属医院金鑫、河南科技大学第一附属医院王新帅、广西医科大学第一附属医院李扬、南阳医学高等专科学校第一附属医院杨秀丽、贝达药业丁列明等学者的TIFFANY研究报告，首次对泰瑞西利联合氟维司群或者单用氟维司群治疗激素受体阳性HER2阴性晚期乳腺癌内分泌治疗耐药患者的有效性和安全性进行随机对照。TIFFANY/BTP-66732 (NCT05433480): A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast CancerOfficial Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Fulvestrant Plus BPI-16350 or Plus Placebo in Patients With HR+, HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer With Disease Progression Following Endocrine Therapy该多中心安慰剂双盲随机对照三期临床研究于2022年5月25日至2023年4月25日在中国69家医院入组激素受体阳性HER2阴性晚期乳腺癌既往内分泌治疗期间疾病进展且接受过不超过一线化疗女性患者274例（年龄中位53.0岁、四分位46.0至60.0岁）按2比1随机分为两组：泰瑞西利（每天一次口服400毫克）联合氟维司群184例（67.2%）或安慰剂联合氟维司群90例（32.8%）直至疾病进展、死亡或由于各种原因停止治疗。主要终点为研究者评定的无进展生存，次要终点包括客观缓解率、总生存和安全性。结果，截至2024年3月31日，中位随访12.9个月，泰瑞西利组与安慰剂组相比：进展或死亡发生率：43.5%比71.1%中位无进展生存期：16.5个月比5.6个月（95%置信区间：12.8～16.6、4.5～9.2）进展或死亡风险比：0.37（95%置信区间：0.27～0.52，P<0.001）可测量病灶客观缓解率：45.6%比12.9%（95%置信区间：37.6%～53.7%、6.1%～23.0%，P<0.001）泰瑞西利组与安慰剂组相比，最常见的≥3级治疗期间不良事件发生率：中性粒细胞减少：15.2%比5.6%贫血：12.0%比4.4%低钾血症：12.0%比0%泰瑞西利组未发生药物相关死亡病例，安慰剂组发生1例药物相关死亡病例。因此，该研究结果表明，对于激素受体阳性HER2阴性晚期乳腺癌既往内分泌治疗期间疾病进展患者，泰瑞西利联合氟维司群与安慰剂联合氟维司群相比，进展或死亡风险降低63%，有统计学意义和临床意义，安全性可控。JAMA Oncol. 2025 Jul 31. IF: 20.1Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor-Positive and ERBB2-Negative Advanced Breast Cancer After Endocrine Therapy: A Randomized Clinical Trial.Tao Z, Zhang J, Zheng Q, Wang Y, Cai L, Xu H, Xu X, Kong X, Ding S, Hao C, Wang H, Zong H, Jin X, Wang X, Li Y, Yang X, Li W, Du X, Chen H, Wu P, Li P, Mao L, Ding L, Hu X, Wang S.Fudan University Shanghai Cancer Center, Shanghai, China; Shanghai Medical College, Fudan University, Shanghai, China; Sun Yat-sen University Cancer Center, Guangzhou, China; Shandong Cancer Hospital, Jinan, China; Harbin Medical University Cancer Hospital, Harbin, China; Weihai Municipal Hospital, Weihai, China; Yichang Central People's Hospital, Yichang, China; Xingtai People's Hospital, Xingtai, China; The Central Hospital of Yongzhou, Yongzhou, China; Tianjin Medical University Cancer Center Institute and Hospital, Tianjing, China; Sichuan Cancer Hospital, Chengdu, China; The First Affiliated Hospital of Zhengzhou Hospital, Zhengzhou, China; The First Affiliated Hospital of Bengbu Medical College, Bengbu, China; The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China; The First Affiliated Hospital of Guangxi Medical University, Nanning, China; The First Affiliated Hospital of Nanyang Medical College, Nanyang, China; Betta Pharmaceuticals Co, Ltd, Hangzhou, China.QUESTION: Does the addition of tibremciclib to fulvestrant prolong progression-free survival (PFS) for patients with hormone receptor-positive (HR+) and ERBB2 (formerly HER2)-negative (ERBB2-) advanced breast cancer (ABC) who experienced progression while receiving prior endocrine therapy (ET)?FINDINGS: This phase 3 randomized clinical trial involved 274 patients with HR+/ERBB2- ABC who experienced progression while receiving prior ET. The combination of tibremciclib and fulvestrant significantly improved PFS compared with the combination of placebo plus fulvestrant; the median PFS was 16.5 (95% CI, 12.8-16.6) months in the tibremciclib arm, and the toxic effects were tolerable.MEANING: The results of this trial suggest that tibremciclib plus fulvestrant provides improvement in PFS for patients with HR+/ERBB2-ABC who experienced progression after ET, with a manageable safety profile.IMPORTANCE: Cyclin-dependent kinase (CDK) 4/6 inhibitors combined with endocrine therapy (ET) are now considered the standard treatment regimen for hormone receptor-positive (HR+) and ERBB2 (formerly HER2)-negative (ERBB2-) advanced breast cancer (ABC). Tibremciclib (BPI-16350), a novel CDK4/6 inhibitor, has demonstrated favorable tolerability and promising antitumor activity as a monotherapy or combined with fulvestrant among patients with HR+/ERBB2- ABC in a phase 1 trial. Further investigations are necessary to assess the efficacy and safety of tibremciclib.OBJECTIVE: To compare tibremciclib plus fulvestrant and placebo plus fulvestrant in terms of efficacy and safety among patients with HR+/ERBB2- ABC who exhibited disease progression after ET.DESIGN, SETTING, AND PARTICIPANTS: The TIFFANY trial was a double-blind, placebo-controlled, phase 3 randomized clinical trial of patients with HR+/ERBB2- ABC who had experienced progression while receiving prior ET and had received no more than 1 line of chemotherapy. This trial was conducted at 69 Chinese centers between May 25, 2022, and April 25, 2023. The data cutoff date for this analysis was March 31, 2024.INTERVENTIONS: Patients were randomly assigned to receive tibremciclib (400 mg, orally, once daily) plus fulvestrant or placebo plus fulvestrant at a 2:1 ratio until disease progression, death, or treatment discontinuation for various reasons.MAIN OUTCOMES AND MEASURES: The primary end point was investigator-assessed progression-free survival (PFS), and the secondary end points included the objective response rate, overall survival, and safety.RESULTS: A total of 274 female patients (median [IQR] age, 53.0 [46.0-60.0] years) were randomly assigned to receive tibremciclib plus fulvestrant (184 [67.2%]) or placebo plus fulvestrant (90 [32.8%]). Among these patients, 144 PFS events occurred (80 in the tibremciclib arm and 64 in the placebo arm), with a median follow-up of 12.9 months for both arms. Tibremciclib plus fulvestrant significantly improved PFS compared with placebo plus fulvestrant (median, 16.5 months [95% CI, 12.8-16.6] vs 5.6 months [95% CI, 4.5-9.2]; hazard ratio, 0.37; 95% CI, 0.27-0.52; P < .001). In patients with measurable disease, tibremciclib plus fulvestrant achieved an objective response rate of 45.6% (95% CI, 37.6%-53.7%) compared with 12.9% (95% CI, 6.1%-23.0%) in the placebo arm (P < .001). The most common grade 3 or higher treatment-emergent adverse events in the tibremciclib vs placebo arm were neutropenia (15.2% vs 5.6%, respectively), anemia (12.0% vs 4.4%, respectively), and hypokalemia (12.0% vs 0%, respectively). No drug-related deaths occurred in the tibremciclib arm, and 1 death occurred in the placebo arm.CONCLUSIONS AND RELEVANCE: The results of this randomized clinical trial suggest that tibremciclib plus fulvestrant was associated with statistically significant and clinically meaningful improvements in PFS compared with placebo plus fulvestrant. Furthermore, tibremciclib plus fulvestrant demonstrated a manageable safety profile in patients with HR+/ERBB2- ABC who experienced progression while receiving prior ET.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05433480PMID: 40742733DOI: 10.1001/jamaoncol.2025.2092ESMO Open. 2025 Jun;10(6):105121. IF: 8.3A phase I dose-escalation and dose-expansion study of tibremciclib, a novel CDK4/6 inhibitor, monotherapy and in combination with fulvestrant in HR-positive/HER2-negative advanced breast cancer.Zhang J, Liu R, Gao S, Chen W, Han X, Wang Z, Zhou H, Wang Y, Chen J, Ma Y, Liu K, Shen Z, Ding L, Li P, Hu X.Fudan University Shanghai Cancer Center, Shanghai, China; Shanghai Medical College, Fudan University, Shanghai, China; Nanchang Third Hospital, Nanchang, China; Anhui Provincial Hospital, Hefei, China; The First Affiliate Hospital of Bengbu Medical University, Bengbu, China; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, China; Yantai Yuhuangding Hospital, Yantai, China; Betta Pharmaceuticals Co., Ltd., Hangzhou, China.HIGHLIGHTSTibremciclib, a novel CDK4/6 inhibitor, shows a favorable safety profile in HR-positive/HER2-negative ABC in phase I study.Tibremciclib plus fulvestrant shows robust efficacy (ORR 53.8%, median PFS 17.0 months) in HR-positive/HER2-negative ABC.Tibremciclib exhibits dose-proportional exposure, long half-life (35.9-51.1 h), and no interaction with fulvestrant.BACKGROUND: Tibremciclib (BPI-16350) is a novel potent selective inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6). This phase I, first-in-human study assessed the tibremciclib monotherapy and combined with fulvestrant in advanced breast cancer (ABC).PATIENTS AND METHODS: This open-label, phase I study (NCT03791112) comprised dose escalation (phase Ia) and expansion (phase Ib). In phase Ia, Chinese patients with advanced solid tumors received tibremciclib monotherapy (50-500 mg orally once daily). Based on the tolerability and preliminary antitumor activity from phase Ia, two dose cohorts (300 or 400 mg orally once daily) were selected in phase Ib to combine with fulvestrant in patients with hormone receptor (HR)-positive/human epidermal growth receptor 2 (HER2)-negative ABC who failed endocrine therapy. The primary endpoints were safety and tolerability, and secondary endpoints included pharmacokinetics (PK) and antitumor activity.RESULTS: In phase Ia, 24 patients with advanced tumors (23 ABC and 1 abdominal liposarcoma) received tibremciclib monotherapy, while in phase Ib, 78 patients with HR-positive/HER2-negative stage IV ABC received tibremciclib plus fulvestrant, with a median age of 56.0 (range 26-66) years and 53.5 (range 33-71) years, respectively. In phase Ia, one dose-limiting toxicity (grade 3 blood creatinine increased) occurred at 500 mg and the maximum tolerated dose was not reached. In phase Ib, the recommended phase II dose (RP2D) was tibremciclib 400 mg plus fulvestrant 500 mg. Frequently reported treatment-emergent adverse events of any grade were grade 1-2 blood creatinine increased, hypertriglyceridemia, and anemia. PK demonstrates dose proportionality, a half-life of ~35.9-51.1 h, and no drug-drug interaction with fulvestrant. In phase Ia, one patient achieved partial response (PR), with a confirmed objective response rate (ORR) of 4.2% and a disease control rate (DCR) of 70.8%. In phase Ib, 42 patients achieved PR, with an ORR of 53.8% and a DCR of 87.2%.CONCLUSIONS: Tibremciclib monotherapy or combined with fulvestrant was well tolerated with the RP2D set at 400 mg plus fulvestrant 500 mg. PK was consistent with dose proportionality. Both regimens showed preliminary antitumor activity in patients with HR-positive/HER2-negative ABC, supporting further evaluation in a phase III study (NCT05433480).KEYWORDS: breast cancer; cyclin-dependent kinase 4 and 6; fulvestrant; safety; tibremciclibPMID: 40403388DOI: 10.1016/j.esmoop.2025.105121（来源：SIBCS）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床3期临床结果临床2期ASH会议

2025-07-27

·ioncology

2025年ESMO年会部分摘要题目公布，一文汇总当前入选的乳腺癌领域中国研究

点击蓝字，关注我们编者按：2025年欧洲肿瘤内科学会年会（ESMO 2025）将于10月17日至21日在德国柏林召开，作为肿瘤学界的年度盛典，ESMO每年都会吸引上万名世界各地的肿瘤学专家参与，为全球学者提供了良好的交流平台。目前，ESMO官网已公布了大会部分口头报告及壁报标题，肿瘤瞭望特将目前乳腺癌领域入选的中国学者投稿研究进行汇总，并诚邀您持续关注重磅研究进展！Breast cancer, early（早期乳腺癌）Mini oral session297MO-Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain: A Prospective, Randomized Phase 3 Trial培非格司亭给药时机与培非格司亭诱导的骨痛：一项前瞻性随机III期试验讲者：Peiyong Li (Guangzhou, China)Posters and ePosters298P - Development and validation of a novel HER2RI assay for predicting the risk of recurrence and survival in Asian population with HER2-positive breast cancer用于预测亚洲HER2阳性乳腺癌患者复发和生存风险的新型HER2RI检测方法的开发和验证讲者：Yi-Kun Kang (Beijing, China)300P - TIME-HER: A Dynamic Predictive Model for Prognosis of HER2-Positive Early Breast Cancer after HER2-targeted TherapyTIME-HER：HER2靶向治疗后HER2阳性早期乳腺癌预后的动态预测模型讲者：Qingyao Shang (Beijing, China)305P - Neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer: three-year outcomes from the MUKDEN 01 studyMUKDEN 01研究三年随访结果：吡咯替尼联合来曲唑及达尔西利新辅助治疗三阳性乳腺癌的疗效分析讲者：刘彩刚 (Shenyang, China)306P - Neoadjuvant SHR-A1811 with or without pyrotinib in HER2-positive breast cancer (MUKDEN 07): A multi-cohort, multicenter, phase II clinical trialMUKDEN 07研究：一项针对HER2阳性乳腺癌的多队列、多中心Ⅱ期临床试验，评估新辅助治疗中SHR-A1811联合或不联合吡咯替尼的疗效讲者：刘彩刚(Shenyang, China)312P - Comparison of survival outcomes between neoadjuvant and adjuvant therapy in patients with T1c, lymph node-negative, and hormone receptor-negative breast cancer: a study based on the SEER database and a Chinese cohortT1c期、淋巴结阴性且激素受体阴性乳腺癌患者新辅助治疗与辅助治疗生存结局的对比研究：基于SEER数据库与中国队列的分析讲者：Shiyu Liang (Chengdu, China)317P - Myeloprotection with Trilaciclib in Hormone Receptor (HR)-Negative early breast cancer receiving adjuvant therapyTrilaciclib在激素受体（HR）阴性早期乳腺癌辅助治疗中的骨髓保护作用讲者：Jiajia Huang (Guangzhou, China)344P - Inadequate ovarian suppression in young premenopausal women with estrogen receptor-positive breast cancer on ovarian suppression therapy接受卵巢功能抑制治疗的年轻绝经前雌激素受体阳性乳腺癌患者卵巢抑制不充分的现象讲者：Dar-Ren Chen (Changhua City, Taiwan)348P - Ten-Year Outcomes of Epirubicin Plus Paclitaxel Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel in Hormone Receptor–Positive, ERBB2-Negative, Node-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial表柔比星联合紫杉醇对比表柔比星联合环磷酰胺序贯紫杉醇治疗激素受体阳性、ERBB2阴性、淋巴结阳性乳腺癌的10年随访结局比较：一项3期随机临床试验讲者：Liuliu Quan (Beijing, China)382P - A modern DCIS-IBC guide board for postoperative upgrading in ductal carcinoma in situ导管原位癌术后升级为浸润性乳腺癌的现代风险评估指南框架讲者：Chenglong Duan (xian, China)383P - Spatial transcriptomics reveals biological disparities in ipsilateral breast tumor recurrence after breast-conserving surgery空间转录组学揭示保乳术后同侧乳腺肿瘤复发的生物学差异讲者：FEILIN QU (Shanghai, China)385P - Is axillary intervention necessary for selected patients with cN0-1 breast cancer after neoadjuvant chemotherapy?新辅助化疗后的cN0-1乳腺癌患者是否有必要进行腋窝干预？讲者：Yuhan Zhang (Xi'an, Shaanxi Province, China)386P - The Innovative Lancet Technique for Breast-Conserving Oncoplastic Surgery in Small- to Medium-Sized Breasts with Tumors in the Lower Inner Quadrant: A Multicenter Retrospective Study (IOS Study)针对中小乳房下内侧象限肿瘤的保乳整形手术创新Lancet技术：一项多中心回顾性研究（IOS研究）讲者：Rui Zhuo (Guilin, China)389P - A Competing Risk Analysis Model to Explore the Impact of Postoperative Radiotherapy for Sentinel Lymph Node Micrometastases or ITCs in Female Breast Cancer竞争风险分析模型探讨术后放疗对女性乳腺癌前哨淋巴结微转移或孤立肿瘤细胞（ITCs）的影响讲者：Yudong Zhou (xian, China)391P - Application of Preoperative 3-dimensional Vascular Reconstruction Assessment in Preventing Ischemic Complications After Nipple-Sparing Mastectomy: A Randomized Controlled Trial术前三维血管重建评估在预防保留乳头乳房切除术后缺血性并发症中的应用：一项随机对照试验讲者：Xiaoqi Zhang (Guangzhou, China)398P - Patient-reported outcomes (PROs) with GnRHa as ovarian function suppression (OFS) treatment in pre-menopausal Chinese patients with hormone receptor-positive (HR+) early breast cancer (EBC): a real-world observational investigationGnRHa作为卵巢功能抑制（OFS）治疗绝经前激素受体阳性（HR+）早期乳腺癌（EBC）患者的患者报告结局（PROs）：一项真实世界观察性研究讲者：Xiyu Liu (Shanghai, China)403P - Axillary Lymph Node Dissection Offers No Survival Benefit in Breast Cancer Patients with Sentinel Lymph Node Micrometastases After Neoadjuvant Therapy腋窝淋巴结清扫术对新辅助治疗后前哨淋巴结微转移的乳腺癌患者无生存获益讲者：Jianing Zhang (Xi'an, China)414P - Prognostic Value of ER reduction rate between pre- and post- Neoadjuvant Chemotherapy in Patients with ER-Positive/HER2-Negative Breast Cancer新辅助化疗前后ER降低率对ER阳性/ HER2阴性乳腺癌患者的预后价值讲者：Shunyi Liu (Fuzhou, China)416P - Diverse adjuvant treatment in triple-negative breast cancer patients with residual disease after neoadjuvant chemotherapy: A single center real-world study新辅助化疗后残留病灶的三阴性乳腺癌患者的多样化辅助治疗：一项单中心真实世界研究讲者：Xi Chen (Beijing, China)417P - Proteomic analysis of residual disease identifies potential prognostic biomarkers of triple-negative breast cancer after neoadjuvant chemotherapy三阴性乳腺癌新辅助化疗后残留病灶的蛋白质组学分析确定潜在的预后生物标志物讲者：Xi Chen (Beijing, China)418P - Impact of BRCAness Status on Prognosis and Chemotherapy Sensitivity in Non-pCR Triple-Negative Breast Cancer Patients After Neoadjuvant TreatmentBRCA样状态对新辅助治疗后未达病理完全缓解（non-pCR）三阴性乳腺癌患者预后及化疗敏感性的影响讲者：Hangcheng Xu (Beijing, China)429eP - Identification of Low Risk Patients with ER+/HER2- Breast Cancer by mRNA-based LRP Model通过基于mRNA的LRP模型识别ER+/HER2-乳腺癌的低危患者讲者：梁旭 (Beijing, China)430eP - Peri-lymph node tattooing with carbon nanoparticles suspension: a novel strategy for targeted axillary dissection in breast cancer纳米碳混悬标记淋巴结周围：一种乳腺癌靶向腋窝清扫的创新策略讲者：Junyuan Lv (Zunyi, China)436eP - ABCB1 gene polymorphism and effectiveness of olanzapine-containing antiemetic prophylaxis for patients receiving adriamycin and cyclophosphamide chemotherapyABCB1基因多态性与接受阿霉素和环磷酰胺化疗患者含奥氮平止吐预防的有效性讲者：Winnie Yeo (Hong Kong, Hong Kong SAR, China)444eP - Impact of Typical Somatic Gene Mutation Characteristics on Homologous Recombination Deficiency in Breast Cancer典型体细胞基因突变特征对乳腺癌同源重组缺陷的影响讲者：Jinsui Du (Xi'an, Shaanxi Province, China)448eP - KBD111 is a highly selective, long-acting and brain-penetrant PARP1 inhibitorKBD111是一种高选择性、长效、能穿透血脑屏障的PARP1抑制剂讲者：Yang Chen (chengdu, China)461eTiP - EXTEND: Neoadjuvant Trastuzumab Deruxtecan (T-DXd) versus Standard Treatment for Medium-risk human epidermal growth factor receptor 2 (HER2)–positive Early Breast CancerEXTEND研究：对比新辅助治疗中德曲妥珠单抗（T-DXd）与标准方案用于中危HER2阳性早期乳腺癌的疗效讲者：李俊杰(Shanghai, China)Breast cancer, locally advanced（局部晚期乳腺癌）Posters and ePosters466P - Efficacy and Safety of JS105, a Selective Inhibitor of Mutant PI3Kα, in Patients with Advanced Cancer选择性突变型PI3Kα抑制剂JS105在晚期癌症患者中的疗效与安全性研究讲者：闫敏 (Zhengzhou, China)468P - The Clinical Significance and Prognostic Impact of stromal tumor infiltrating lymphocytes in HER2-Positive Breast Cancer: Including a Neoadjuvant Subgroup AnalysisHER2阳性乳腺癌间质肿瘤浸润淋巴细胞的临床意义和预后影响：包括新辅助治疗亚组分析讲者：Yujing Chang (Chengdu, China)470P - Neoadjuvant cadonilimab (anti-PD-1/CTLA-4 bispecific antibody) plus chemotherapy in early or locally advanced triple-negative breast cancer: supplementary biomarker analyses from CABIN trial新辅助cadonilimab（抗pd -1/CTLA-4双特异性抗体）联合化疗治疗早期或局部晚期三阴性乳腺癌：来自CABIN试验的补充生物标志物分析讲者：TAO WU (Changde City, China)472P - The mechanism and preclinical translational research of targeted inhibition of ATM enhancing the therapeutic efficacy of PD-1/PD-L1 inhibitors in triple-negative breast cancer by modulating CD8⁺T cells in the tumor immune microenvironment靶向抑制ATM通过调控肿瘤免疫微环境中CD8⁺T细胞增强PD-1/PD-L1抑制剂治疗三阴性乳腺癌的机制及临床前转化研究讲者：Xiaojing Guo (Tianjin, China)473P - Neoadjuvant Trilaciclib plus chemotherapy and anti-PD1-antibody for locally advanced triple-negative breast cancer: Preliminary short-term efficacy and safety results from a single-arm, multicenter, phase II trial新辅助治疗中Trilaciclib联合化疗及抗PD-1抗体治疗局部晚期三阴性乳腺癌：一项单臂、多中心Ⅱ期试验的初步短期疗效与安全性结果讲者：Jiaxuan Liu (Beijing, China)479P - H4K8la/CXCL10-driven M2 polarization via tumor cell-macrophage lactate feedback loop mediates doxorubicin resistance in TNBCH4K8la/CXCL10通过肿瘤细胞-巨噬细胞乳酸反馈回路驱动M2型巨噬细胞极化，介导三阴性乳腺癌对多柔比星的耐药性讲者：Qingqing Wang (Wuhan, China)（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期临床结果

2025-07-14

·ioncology

宋传贵教授：ASCO年会乳腺癌新辅助治疗——聚焦升阶梯与降阶梯治疗新进展与未来发展趋势

点击上方蓝字关注我们编者按：由广东省预防医学会主办，广东省人民医院协办的2025广东省预防医学会乳腺癌防治专业委员会学术研讨会日前于广州圆满落幕。复旦大学附属肿瘤医院福建医院（福建省肿瘤医院）宋传贵教授在本次会议上带来了“2025 ASCO乳腺癌新辅助治疗进展”的讲课，会后，肿瘤瞭望特邀采访了宋传贵教授，请他就2025年ASCO年会新辅助治疗研究的整体趋势及相关进展进行了介绍。01《肿瘤瞭望》：2025年ASCO年会中，乳腺癌新辅助治疗领域有多项突破性研究成果公布，尤其是降阶梯治疗、靶向联合方案等议题备受关注。王坤教授公布的neoCARHP研究结果显示，THP方案在HER2阳性早期乳腺癌治疗中达到非劣效于含卡铂（TCbHP）方案的pCR率，且安全性更优。您如何评价这一结果对临床实践的影响？作为国内乳腺癌领域专家，请您为我们总结下2025年ASCO年会新辅助治疗研究的整体趋势。宋传贵教授复旦大学附属肿瘤医院福建医院（福建省肿瘤医院）众所周知，HER2阳性早期乳腺癌新辅助治疗，已经形成了靶向联合化疗的治疗模式。目前，HER2阳性早期乳腺癌患者新辅助治疗的pCR率可以达到60%甚至更高，但当今临床治疗的关键点在于，如何减轻乳腺癌患者药物治疗带来的毒性，同时保持治疗疗效。广东省人民医院王坤教授在2025年ASCO大会带来了HER2阳性早期乳腺癌新辅助治疗的neoCARHP研究，结果显示，THP方案pCR率非劣效于TCbHP方案（64.1% vs 65.9%）。目前来看，对于铂类添加与否，临床一直存在争议，最近公布的多项临床研究也证实，“去铂类”其实并不影响患者整体的pCR率，同时又能减少铂类带来的血液学和消化道等不良反应。△neoCARHP研究pCR率未来，对于HER2阳性乳腺癌的新辅助治疗，更多的是朝着“降阶梯”治疗的方向发展，无论是“去铂类”还是缩短新辅助治疗的疗程（降低治疗强度），甚至未来可能实现应用单一的ADC药物来代替现有的三药/四药联合治疗方案，以上这些均代表了未来以更少的药物来争取相似或者更好的治疗疗效，同时减少多药化疗引起的不良反应的发展趋势。目前新辅助治疗研究不止于此。尽管现在许多新辅助治疗研究仍以pCR为主要研究终点，但可以看到一个趋势，即大家越来越关注长期生存，因此很多研究以iDFS甚至OS作为主要研究终点，这类研究更能体现我们对乳腺癌患者全程治疗的关注。当前的临床研究多聚焦于ADC药物，由此可见，我们对ADC药物治疗还是充满期待的。复旦大学附属肿瘤医院李俊杰教授在2024年SABCS大会上报告的FASCINATE-N研究结果显示，SHR-A1811单药治疗HER2阳性早期乳腺癌的疗效与多药联合取得的pCR率相当。未来，他们还会进行更长时间随访，若能证明SHR-A1811单药对长期预后的结果相似，或将改变当前临床实践。当然，目前我们不能简单认为一项或少数几项研究数据就能改变当前临床实践，因为需要根据研究中的入组人群进一步区分。若“去卡铂”药物方案可行，目前可能仅在相对早期患者中试用，想要大规模运用可能还需等待时机，但这至少也是“降阶梯”治疗进步的表现。此外，今年ASCO年会上WSG的联合分析等研究数据公布，也体现了这一趋势，让我们对目前新辅助治疗的理解更进一步。02《肿瘤瞭望》：DAWNA-A研究证实，达尔西利联合内分泌治疗可显著改善HR+/HER2-高危早期乳腺癌患者的无浸润性疾病生存期（iDFS）。您如何看待CDK4/6抑制剂从晚期治疗向辅助治疗的延伸？宋传贵教授复旦大学附属肿瘤医院福建医院（福建省肿瘤医院）事实上，对于乳腺癌患者的治疗，不同分子亚型患者所运用的治疗策略是不一样的，一些患者需要进行“降阶梯”治疗，而另一些患者则需要“升阶梯”治疗。如对于HR+乳腺癌患者，我们是否需要在传统内分泌治疗的基础上进行“加码”？现在多项相关研究结果的公布，也使患者的治疗之路越来越清晰，治疗选择也越来越多样化。以高危HR+早期乳腺癌患者治疗为例，这类患者的复发风险主要存在于第二个5年，我们不仅要强调对于绝经前或者围绝经期患者的卵巢功能抑制，同时也会在患者内分泌治疗强度和时间上给予相应调整。如对于早期高危患者我们会在OFS+内分泌基础上联合CDK4/6抑制剂或者适当延长患者内分泌治疗的时间（内分泌治疗时间可延长至10年）。从monarchE研究到NATELEE研究，再到2025年ASCO年会上邵志敏教授报道的DAWNA-A研究，均证明了CDK4/6抑制剂联合内分泌治疗能使乳腺癌患者的生存期延长。DAWNA-A研究更是基于中国患者人群数据，入组了超过5000例患者的数据，结果证实，达尔西利+内分泌治疗相较于安慰剂+内分泌治疗有更多的生存获益（2年iDFS达尔西利组94.7% vs安慰剂组90.2%，HR=0.56（0.43-0.71），P＜0.0001）。△DAWNA-A研究iDFSCDK4/6抑制剂在HR+早期乳腺癌患者治疗中的适应症获批，对于早期高危乳腺癌患者而言，治疗选择增多的同时，也能使其复发和转移风险下降，能为患者争取更多的治疗希望和治愈空间。因此，我们对DAWNA-A研究也充满了更多期待。宋传贵教授复旦大学附属肿瘤医院福建医院（福建省肿瘤医院）主任医师、教授、博士生导师乳腺肿瘤学科带头人/乳腺肿瘤诊治中心执行主任中国抗癌协会乳腺癌专业委员会常委中国抗癌协会肿瘤靶向治疗专委会常委福建省抗癌协会乳腺癌专业委员会主任委员中华医学会肿瘤分会乳腺肿瘤学组成员CSCO乳腺癌专家委员会委员（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议抗体药物偶联物临床结果临床1期

100 项与羟乙磺酸达尔西利相关的药物交易

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适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	中国	江苏恒瑞医药股份有限公司	2021-12-31

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适应症	最高研发状态	国家/地区	公司	日期
去势敏感前列腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2023-10-19
HER2 阴性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2021-04-30
HR阳性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2021-04-30
淋巴结阳性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2021-04-30
晚期乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2019-06-13
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2019-06-13
转移性去势抵抗性前列腺癌	临床2期	中国	江苏恒瑞医药股份有限公司	2024-07-31
ER阳性/HER2阴性乳腺癌	临床2期	中国	山东盛迪医药有限公司	2023-12-20
尤文肉瘤	临床2期	中国	江苏恒瑞医药股份有限公司	2023-07-01
转移性软组织肉瘤	临床2期	中国	江苏恒瑞医药股份有限公司	2023-07-01

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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


NCT05586841 (ASCO2025) 人工标引	临床1期	HR阳性/HER2阴性乳腺癌 HER2 Negative \| Hormone Receptor Positive	22	dalpiciclib + chidamide	鑰製繭餘遞壓窪築糧憲(繭觸艱繭製鑰夢廠襯壓) = the MTD was established as Group C (dalpiciclib 100 mg/d, chidamide 25 mg BIW). 鹹繭選糧積艱襯積顧齋 (構網廠簾餘襯製鑰憲網 )	积极	2025-05-30
				dalpicicldalpiciclibchidamide (Group C: dalpiciclib 100 mg/d, chidamide 25 mg BIW)
NCT06495515 (ASCO2025)	临床2期	HR阳性HER2阴性淋巴结阳性乳腺癌一线 HR+ \| HER2-negative	26	Dalpiciclib plus Toremifene	廠糧鏇選窪鹽鑰鏇廠齋(憲遞窪襯廠膚壓齋齋糧) = 網襯觸夢蓋範簾網願夢鑰壓網積膚糧製淵鏇壓 (淵構積襯簾簾襯壓窪齋 ) 更多	积极	2025-05-30
NCT05806671 (Bayesian optimal phase Ⅱ trial, ASCO2025)	临床2期	HR阳性/HER2低表达乳腺癌	30	Dalpiciclib plus Fulvestrant and Pyrotinib	淵醖簾積艱齋鹽夢鬱蓋(憲簾選網廠遞夢餘網範) = 選壓夢齋淵願夢網網淵簾獵夢積選製壓構觸鏇 (壓積鬱醖醖蓋鹹醖糧鑰 ) 更多	积极	2025-05-30
				Abemaciclib	廠醖餘淵鹹遞蓋構製構(膚鏇範鏇網憲願鹽鹹觸) = 艱鏇選願憲蓋憲築糧簾選鹹夢鹽醖遞遞齋齋淵 (蓋簾範淵廠繭觸衊襯憲, 1.1 ~ 5.1)
NCT05640778 (DANCER, ASCO2025)	临床2期	HER2 阴性乳腺癌新辅助 ctDNA clearance \| Olink proteomic analyses \| somatic variation profiling ... 更多	30	dalpiciclib (Good Responders (GR))	觸艱鹽淵範鏇憲膚鹹鹹(繭憲鬱鹽獵鑰選簾憲艱) = significant shift in copy number pattern after treatment at S 觸網壓糧窪鬱範鏇範醖 (範鏇鬱鹽遞鑰蓋願選鹹 )	积极	2025-05-30
				dalpiciclib (Moderate Responders (MR))
NCT04842617 (DAWNA-A, ASCO2025)	临床3期	早期乳腺癌辅助 HR+ \| HER2-	5,274	Dalpiciclib (Dalp) + Endocrine Therapy (ET)	獵糧網鑰艱壓鑰醖廠鏇(襯簾鬱醖簾淵獵顧糧醖): HR = 0.56 (95% CI, 0.43 ~ 0.71)	积极	2025-05-30
				Placebo + Endocrine Therapy (ET)
CTR20210652 (DAWNA-A \| SHR6390-III-303, NEWS) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌 HER2 Negative \| Hormone Receptor Positive	5,000	羟乙磺酸达尔西利+内分泌治疗	選齋艱鑰糧衊遞廠衊簾(鏇壓齋鹽廠顧醖艱窪艱) = 达尔西利联合内分泌治疗，较安慰剂联合内分泌治疗，可显著降低患者复发风险，提高患者无侵袭性疾病生存期淵鏇醖鏇觸網淵範壓鏇 (襯繭壓膚繭鹹鹹繭獵網 ) 达到	积极	2025-02-23
				安慰剂+内分泌治疗
NCT05512780 (DARLING 01, Pubmed \| Breast Cancer Res) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌新辅助 HER2 Negative \| Hormone Receptor Positive	29	Dalpiciclib + Letrozole	顧衊夢憲醖繭繭醖窪糧(壓醖鏇衊壓窪鹹繭簾齋) = 願鬱齋鑰蓋餘窪壓壓遞齋壓顧襯衊鑰窪觸憲壓 (廠窪夢憲鬱製願簾憲蓋 ) 更多	积极	2025-02-13
NCT03966898 (DAWNA-2, SABCS2024) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌一线 Hormone Receptor Positive \| HER2 Negative	456	Dalpiciclib + Letrozole/Anastrozole	鑰鬱製蓋夢憲鑰觸製簾(襯範範壓夢蓋網願繭構) = 鹽築壓製壓鹽鹹壓憲觸醖鑰範鬱廠鏇夢構憲選 (夢鑰憲齋選壓製構淵淵, 29.6 ~ 39.0) 更多	积极	2024-12-12
				Placebo + Letrozole/Anastrozole	鑰鬱製蓋夢憲鑰觸製簾(襯範範壓夢蓋網願繭構) = 膚壓觸構構築襯鏇觸製醖鑰範鬱廠鏇夢構憲選 (夢鑰憲齋選壓製構淵淵, 16.5 ~ 22.5) 更多
NCT05431504 (SABCS2024 \| NEWS) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌 Hormone Receptor Positive \| HER2 Negative	53	Dalpiciclib plus ET	鬱願蓋憲鏇鏇壓壓蓋範(淵範鑰構蓋簾襯齋簾膚) = 鏇蓋鑰艱淵製蓋壓衊遞鬱鏇艱廠餘襯願積願顧 (憲餘繭選壓餘淵選壓醖, 7.59 ~ NE) 更多	积极	2024-11-26
				Chemotherapy (external control group)	鬱願蓋憲鏇鏇壓壓蓋範(淵範鑰構蓋簾襯齋簾膚) = 窪壓淵鑰餘積製鬱壓襯鬱鏇艱廠餘襯願積願顧 (憲餘繭選壓餘淵選壓醖, 2.92 ~ 5.91) 更多
NCT06009627 (ESMO2024) 人工标引	临床2期	绝经前乳腺癌新辅助 HER2 Negative \| Hormone Receptor Positive	32	Dalpiciclib, Exemestane, and Goserelin	觸壓憲觸遞夢鏇遞範鏇(鹽構製齋廠膚膚夢醖壓) = 製築憲顧醖鏇窪選憲衊衊觸網範襯廠夢蓋範築 (鹽衊醖遞積艱鹽範夢鏇 )	积极	2024-09-16
				TAC (docetaxel, doxorubicin, and cyclophosphamide)	觸壓憲觸遞夢鏇遞範鏇(鹽構製齋廠膚膚夢醖壓) = 膚艱簾繭簾願鹹鏇築糧衊觸網範襯廠夢蓋範築 (鹽衊醖遞積艱鹽範夢鏇 )