Progress of important clinical research on breast cancer in China in 2024

Xin YANG; Qianfeng SHI; Qiang LIU

doi:10.19401/j.cnki.1007-3639.2025.02.003

您当前的位置：

首页 >

文章列表页 >

Progress of important clinical research on breast cancer in China in 2024

Specialist's Commentary | 更新时间：2025-12-31

- Progress of important clinical research on breast cancer in China in 2024
- China Oncology Vol. 35, Issue 2, Pages: 167-175(2025)
- 作者机构：
  
  1. 中山大学孙逸仙纪念医院乳腺外科，广东广州 510120
  2. 中山大学孙逸仙纪念医院乳腺肿瘤中心，广东广州 510120
- 作者简介：
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2025.02.003
  CLC： R737.9
- Received：06 January 2025，
  
  Revised：2025-01-31，
  
  Published：28 February 2025
- 稿件说明：
移动端阅览
Xin YANG, Qianfeng SHI, Qiang LIU. Progress of important clinical research on breast cancer in China in 2024[J]. China Oncology, 2025, 35(2): 167-175.
DOI：

Xin YANG, Qianfeng SHI, Qiang LIU. Progress of important clinical research on breast cancer in China in 2024[J]. China Oncology, 2025, 35(2): 167-175. DOI： 10.19401/j.cnki.1007-3639.2025.02.003.

摘要

乳腺癌是全球女性患者发病率最高的癌症，严重威胁女性的健康。2024年，中国学者在乳腺癌临床研究的各个方面都有很好的进展：在外科手术方面，新型光学成像技术为手术边缘的准确评估助力，靶向腋窝淋巴结清扫（target axillary dissection，TAD）继续为手术降阶梯治疗提供循证医学证据，影像组学联合人工智能（artificial intelligence，AI）也有助于手术决策。在靶向治疗方面，酪氨酸激酶抑制剂（tyrosine kinase inhibitor，TKI）类药物表现出优秀的临床结局，其中PILHLE-001研究探索了吡咯替尼新的用药亚型，为管腔型/人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）低表达乳腺癌提供新的治疗思路，安罗替尼和阿帕替尼的疗效和安全性也均可靠；双重靶向HER2方案用于早期HER2阳性患者的新辅助治疗（neoadjuvant therapy，NAT）及辅助治疗较单靶方案组显著获益，提高了患者的生存率；各类抗体药物偶联物（antibody-drug conjugate，ADC）也均展现出良好的临床应用价值，明显改善了患者的生存获益，同时，中国自己研发的新药也走向国际舞台，国际影响力日益增大；此外，免疫治疗和基于复旦分型的精准治疗也均显示出不同程度的生存改善。在化疗方面，研究者探索了不同的NAT策略。在内分泌治疗方面，进一步巩固了CDK4/6抑制剂（CDK4/6 inhibitor，CDK4/6i）在晚期激素受体阳性/HER2阴性乳腺癌中的重要地位，并探讨了既往尚未确定的促性腺激素释放激素激动剂（gonadotrophin releasing hormone analogue，GnRHa）用药剂型等问题。在放疗方面，局部放疗联合靶向治疗显著延长了HER2阳性脑转移乳腺癌患者的生存期，还针对放疗相关心脏毒性不良反应等问题进行了优化。在此，本文总结2024年中国乳腺癌领域重要的临床研究进展，为相关领域的学者提供参考。

Abstract

Breast cancer

is the cancer type with highest incidence rate in women globally. To improve the treatment for breast cancer patients

Chinese scientists have done extensive research on breast cancer. Reviewing the progress made in 2024

Chinese scholars have achieved significant advancements in various aspects of breast cancer research. In the field of surgery

new optical imaging techniques have aided the accurate assessment of surgical margins

and targeted axillary dissection (TAD) continues to provide evidence-based support for de-escalation therapy in surgery. Radiomics combined with artificial intelligence (AI) also assists in surgical decision-making. In targeted therapy

tyrosine kinase inhibitors (TKIs) have shown excellent clinical outcomes. The PILHLE-001 study explored new subtypes for the use of pyrotinib

offering new therapeutic approaches for luminal/human epidermal growth factor receptor 2 (HER2) low breast cancer. The efficacy and safety of anlotinib and apatinib are also reliable. Dual-targeted HER2 regimens in neoadjuvant therapy (NAT) and adjuvant therapy for early HER2-positive patients have demonstrated significant benefits over single-target regimens

improving survival rates. Various antibody-drug conjugates (ADCs) have shown significant clinical applicability

enhancing patient survival benefits

and novel drugs developed in China are making their way onto the international stage

increasing their global influence. Additionally

immunotherapy and precision treatment based on Fudan subtypes have shown varied degrees of survival improvement. In chemotherapy

different NAT strategies have been explored

offering more treatment options for doctors and patients. In endocrine therapy

the critical role of CDK4/6 inhibitors (CDK4/6i) in advanced hormone receptor positive/HER2-negative breast cancer has been further solidified

and issues concerning previously undetermined drug formulations of gonadotrophin releasing hormone analogue (GnRHa) have been examined. In radiotherapy

local radiotherapy combined with targeted therapy has significantly extended the survival of HER2-positive breast cancer patients with brain metastases

and optimizations have been made regarding the cardiotoxic side effects associated with radiotherapy. This article summarized the key clinical research on breast cancer in China in 2024

providing a reference for scholars and experts in related fields.

关键词

Keywords

references

BRAY F , LAVERSANNE M , SUNG H , et al . Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J ] . CA Cancer J Clin , 2024 , 74 ( 3 ): 229 - 263 .

郑荣寿 , 陈茹 , 韩冰峰 , 等 . 2022年中国恶性肿瘤流行情况分析 [J ] . 中华肿瘤杂志 , 2024 , 46 ( 3 ): 221 - 231 .

ZHENG R S , CHEN R , HAN B F , et al . Cancer incidence and mortality in China, 2022 [J ] . Chin J Oncol , 2024 , 46 ( 3 ): 221 - 231 .

ZHANG S W , YANG B , YANG H P , et al . Potential rapid intraoperative cancer diagnosis using dynamic full-field optical coherence tomography and deep learning: a prospective cohort study in breast cancer patients [J ] . Sci Bull (Beijing) , 2024 , 69 ( 11 ): 1748 - 1756 .

BOUGHEY J C , BALLMAN K V , LE-PETROSS H T , et al . Identification and resection of clipped node decreases the false-negative rate of sentinel lymph node surgery in patients presenting with node-positive breast cancer (T0-T4, N1-N2) who receive neoadjuvant chemotherapy: results from ACOSOG Z1071 (alliance) [J ] . Ann Surg , 2016 , 263 ( 4 ): 802 - 807 . DOI: 10.1097/SLA.0000000000001375 http://doi.org/10.1097/SLA.0000000000001375

BOILEAU J F , POIRIER B , BASIK M , et al . Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study [J ] . J Clin Oncol , 2015 , 33 ( 3 ): 258 - 264 .

KUEMMEL S , HEIL J , RUELAND A , et al . A prospective, multicenter registry study to evaluate the clinical feasibility of targeted axillary dissection (TAD) in node-positive breast cancer patients [J ] . Ann Surg , 2022 , 276 ( 5 ): e553-e562.

CHEN X C , LU Z D , WANG C Z , et al . Targeted axillary dissection after neoadjuvant chemotherapy for highly selective patients with initial CN1 breast cancer: a single-center prospective trial [J ] . Chin Med J (Engl) , 2024 , 137 ( 12 ): 1421 - 1430 .

ZHU T , HUANG Y H , LI W , et al . Multifactor artificial intelligence model assists axillary lymph node surgery in breast cancer after neoadjuvant chemotherapy: multicenter retrospective cohort study [J ] . Int J Surg , 2023 , 109 ( 11 ): 3383 - 3394 .

LI W , HUANG Y H , ZHU T , et al . Noninvasive artificial intelligence system for early predicting residual cancer burden during neoadjuvant chemotherapy in breast cancer [J ] . Ann Surg , 2024 .

LI X , YANG C Y , WAN H , et al . Discovery and development of pyrotinib: a novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor with favorable safety profiles for the treatment of breast cancer [J ] . Eur J Pharm Sci , 2017 , 110 : 51 - 61 . DOI: S0928-0987(17)30043-X http://doi.org/S0928-0987(17)30043-X

MA F , OUYANG Q C , LI W , et al . Pyrotinib or lapatinib combined with capecitabine in HER2-positive metastatic breast cancer with prior taxanes, anthracyclines, and/or trastuzumab: a randomized, phase Ⅱ study [J ] . J Clin Oncol , 2019 , 37 ( 29 ): 2610 - 2619 .

YAN M , BIAN L , HU X C , et al . Pyrotinib plus capecitabine for human epidermal growth factor receptor 2-positive metastatic breast cancer after trastuzumab and taxanes (PHENIX): a randomized, double-blind, placebo-controlled phase 3 study [J ] . Transl Breast Cancer Res , 2020 , 1 : 13 .

XU B H , YAN M , MA F , et al . Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial [J ] . Lancet Oncol , 2021 , 22 ( 3 ): 351 - 360 . DOI: 10.1016/S1470-2045(20)30702-6 http://doi.org/10.1016/S1470-2045(20)30702-6

MA F , YAN M , LI W , et al . Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial [J ] . BMJ , 2023 , 383 : e076065 .

GONG C , XIA Y , ZHU Y Y , et al . Preclinical study and phase 2 trial of neoadjuvant pyrotinib combined with chemotherapy in luminal/HER2-low breast cancer: PILHLE-001 study [J ] . Cell Rep Med , 2024 , 5 ( 11 ): 101807 .

SYED Y Y . Anlotinib: first global approval [J ] . Drugs , 2018 , 78 ( 10 ): 1057 - 1062 . DOI: 10.1007/s40265-018-0939-x http://doi.org/10.1007/s40265-018-0939-x

LIANG Y , LIU J , GE J , et al . Safety and efficacy of anlotinib combined with taxane and lobaplatin in neoadjuvant treatment of clinical stage Ⅱ/Ⅲ triple-negative breast cancer in China (the neoALTAL trial): a single-arm, phase 2 trial [J ] . EClinicalMedicine , 2024 , 71 : 102585 .

LI J , QIN S K , XU J M , et al . Randomized, double-blind, placebo-controlled phase Ⅲ trial of apatinib in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction [J ] . J Clin Oncol , 2016 , 34 ( 13 ): 1448 - 1454 .

QIN S K , LI Q , GU S Z , et al . Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial [J ] . Lancet Gastroenterol Hepatol , 2021 , 6 ( 7 ): 559 - 568 .

HU N L , ZHU A J , SI Y R , et al . A phase Ⅱ, single-arm study of apatinib and oral etoposide in heavily pre-treated metastatic breast cancer [J ] . Front Oncol , 2021 , 10 : 565384 .

LAN C Y , WANG Y , XIONG Y , et al . Apatinib combined with oral etoposide in patients with platinum-resistant or platinum-refractory ovarian cancer (AEROC): a phase 2, single-arm, prospective study [J ] . Lancet Oncol , 2018 , 19 ( 9 ): 1239 - 1246 .

LI H , LIU J , LIU Y , et al . VP2-2024: Fuzuloparib with or without apatinib in HER2 - metastatic breast cancer (mBC) patients (pts) with germline BRCA1/2 mutations (g BRCA1/2 m): a randomized phase Ⅲ trial [J ] . Ann Oncol , 2024 , 35 ( 6 ): 574 - 575 .

VON MINCKWITZ G , PROCTER M , DE AZAMBUJA E , et al . Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer [J ] . N Engl J Med , 2017 , 377 ( 2 ): 122 - 131 .

PICCART M , PROCTER M , FUMAGALLI D , et al . Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer in the APHINITY trial: 6 years' follow-up [J ] . J Clin Oncol , 2021 , 39 ( 13 ): 1448 - 1457 . DOI: 10.1200/JCO.20.01204 http://doi.org/10.1200/JCO.20.01204

HUANG L , PANG D , YANG H J , et al . Neoadjuvant-adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase Ⅲ PEONY trial [J ] . Nat Commun , 2024 , 15 ( 1 ): 2153 .

THOMAS A , TEICHER B A , HASSAN R . Antibody-drug conjugates for cancer therapy [J ] . Lancet Oncol , 2016 , 17 ( 6 ): e254-e262.

FU Z W , LI S J , HAN S F , et al . Antibody drug conjugate: the “biological missile” for targeted cancer therapy [J ] . Signal Transduct Target Ther , 2022 , 7 : 93 .

CHAU C H , STEEG P S , FIGG W D . Antibody-drug conjugates for cancer [J ] . Lancet , 2019 , 394 ( 10200 ): 793 - 804 . DOI: S0140-6736(19)31774-X http://doi.org/S0140-6736(19)31774-X

XU B H , WANG S S , YAN M , et al . Sacituzumab govitecan in HR + HER2 - metastatic breast cancer: the randomized phase 3 EVER-132-002 trial [J ] . Nat Med , 2024 , 30 ( 12 ): 3709 - 3716 .

XU B H , YIN Y M , FAN Y , et al . Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): results from the phase Ⅲ OptiTROP-Breast01 study [J ] . J Clin Oncol , 2024 , 42 ( 16_suppl ): 104 .

ZHANG T , YOU L F , XU J Y , et al . Abstract LB031: SHR-A1811, a novel anti-HER2 ADC with superior bystander effect, optimal DAR and favorable safety profiles [J ] . Cancer Res , 2023 .

YAO H R , YAN M , TONG Z S , et al . Safety, efficacy, and pharmacokinetics of SHR-A1811, a human epidermal growth factor receptor 2-directed antibody-drug conjugate, in human epidermal growth factor receptor 2-expressing or mutated advanced solid tumors: a global phase I trial [J ] . J Clin Oncol , 2024 , 42 ( 29 ): 3453 - 3465 .

YAO H . Efficacy and safety of SHR-A1811, an anti-HER2 antibody-drug conjugate (ADC), in 391 heavily pretreated multiple solid tumors with HER2-expression or mutations: a global, multi-center, first-in-human, phase 1 study [C ] . SABCS , 2024 : PS8 - 08 .

LI Q , CHENG Y , TONG Z S , et al . HER2-targeting antibody drug conjugate FS-1502 in HER2-expressing metastatic breast cancer: a phase Ⅰa/Ⅰb trial [J ] . Nat Commun , 2024 , 15 ( 1 ): 5158 .

WANG J Y , LIU Y J , ZHANG Q Y , et al . Disitamab vedotin, a HER2-directed antibody-drug conjugate, in patients with HER2-overexpression and HER2-low advanced breast cancer: a phase Ⅰ/Ⅰb study [J ] . Cancer Commun (Lond) , 2024 , 44 ( 7 ): 833 - 851 .

ZHENG C H , LIU Y B , WANG X E , et al . Clinical efficacy and biomarker analysis of neoadjuvant camrelizumab plus chemotherapy for early-stage triple-negative breast cancer: a experimental single-arm phase Ⅱ clinical trial pilot study [J ] . Int J Surg , 2024 , 110 ( 3 ): 1527 - 1536 .

OUYANG Q , WANG X , TIAN C , et al . 347MO The safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC) [J ] . Ann Oncol , 2024 , 35 : S360-S361.

FAN L , WANG Z H , MA L X , et al . Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial [J ] . Lancet Oncol , 2024 , 25 ( 2 ): 184 - 197 . DOI: 10.1016/S1470-2045(23)00579-X http://doi.org/10.1016/S1470-2045(23)00579-X

CHEN X C , JIAO D C , QIAO J H , et al . De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive early breast cancer (HELEN-006): a multicentre, randomised, phase 3 trial [J ] . Lancet Oncol , 2025 , 26 ( 1 ): 27 - 36 .

WANG C , YUAN L , WU X J , et al . Taxane combined with lobaplatin or anthracycline for neoadjuvant chemotherapy of triple-negative breast cancer: a randomized, controlled, phase Ⅱ study [J ] . BMC Med , 2024 , 22 ( 1 ): 252 .

SHEN G S , REN D F , ZHAO F X , et al . Effect of adding electroacupuncture to standard triple antiemetic therapy on chemotherapy-induced nausea and vomiting: a randomized controlled clinical trial [J ] . J Clin Oncol , 2024 , 42 ( 34 ): 4051 - 4059 .

BINGHE XU E A . Dalpiciclib versus placebo in combination with letrozole or anastrozole as first-line treatment for women with HR + /HER2 - advanced breast cancer: prespecified final analysis of progression-free survival of the phase 3 DAWNA-2 trial [C ] . SABCS , 2024 : PS2 - 01 .

WANG J Y , ZHANG Q Y , LI H P , et al . Bireociclib plus fulvestrant for advanced HR + /HER2 - breast cancer progressing after endocrine therapy: interim analysis of a phase 3 trial (BRIGHT-2) [J ] . J Clin Oncol , 2024 , 42 ( 16_suppl ): 1058 .

HU X , TAO Z , WANG S , et al . 320MO Tibremciclib (BPI-16350) plus fulvestrant in patients with HR + /HER2 - advanced breast cancer after progressing on endocrine therapy: a randomized, multicenter, double-blind, phase Ⅲ study [J ] . Ann Oncol , 2024 , 35 : S349 .

PAGANI O , WALLEY B A , FLEMING G F , et al . Adjuvant exemestane with ovarian suppression in premenopausal breast cancer: long-term follow-up of the combined TEXT and SOFT trials [J ] . J Clin Oncol , 2023 , 41 ( 7 ): 1376 - 1382 .

BAEK S Y , NOH W C , AHN S H , et al . Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: an 8-year follow-up of the ASTRRA trial [J ] . J Clin Oncol , 2023 , 41 ( 31 ): 4864 - 4871 .

LIN J N , OUYANG Y Y , LI Y D , et al . Different dosage forms of gonadotropin-releasing hormone agonist with endocrine therapy in premenopausal hormone receptor-positive breast cancer [J ] . J Natl Cancer Inst , 2024 , 116 ( 10 ): 1587 - 1597 .

Early Breast Cancer Trialists Collaborative Group (EBCTCG) , DARBY S , MCGALE P , et al . Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10 801 women in 17 randomised trials [J ] . Lancet , 2011 , 378 ( 9804 ): 1707 - 1716 .

Early Breast Cancer Trialists Collaborative Group (EBCTCG) , MCGALE P , TAYLOR C , et al . Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials [J ] . Lancet , 2014 , 383 ( 9935 ): 2127 - 2135 . DOI: 10.1016/S0140-6736(14)60488-8 http://doi.org/10.1016/S0140-6736(14)60488-8

YANG Z Z , MENG J , MEI X , et al . Brain radiotherapy with pyrotinib and capecitabine in patients with ERBB2-positive advanced breast cancer and brain metastases: a nonrandomized phase 2 trial [J ] . JAMA Oncol , 2024 , 10 ( 3 ): 335 - 341 .

CAO L , OU D , QI W X , et al . A randomized trial of early cardiotoxicity in breast cancer patients receiving postoperative IMRT with or without serial cardiac dose constraints [J ] . Int J Cancer , 2025 , 156 ( 6 ): 1213 - 1224 .

张琪 , 修秉虬 , 吴炅 . 2023年中国乳腺癌重要临床研究成果及最新进展 [J ] . 中国癌症杂志 , 2024 , 34 ( 2 ): 135 - 142 . DOI: 10.19401/j.cnki.1007-3639.2024.02.001 http://doi.org/10.19401/j.cnki.1007-3639.2024.02.001

ZHANG Q , XIU B Q , WU J . Progress of important clinical research of breast cancer in China in 2023 [J ] . China Oncol , 2024 , 34 ( 2 ): 135 - 142 .

Views

3032

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Progress of important clinical research of breast cancer in China in 2023

Progress of important clinical research on breast cancer in China in 2025

Guidelines for breast cancer diagnosis and treatment by China Anti-Cancer Association (2026 edition)

Progress and prospects of CENPA-driven chromosomal instability in breast cancer: mechanisms, prognostic implications, and therapeutic perspectives

A study of 30-year trends in incidence and mortality risks of breast cancer among young women in China

Related Author

Qi ZHANG

Bingqiu XIU

Jiong WU

DONG Zixian

LI Zhedong

LI Muyao

YU Xinmiao

JIN Feng

Related Institution

Department of Breast Surgery, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University

Department of Collaborative Innovation Center for Cancer Medicine, Fudan University

Department of Breast Surgery, the First Affiliated Hospital of China Medical University

Department of Breast Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Department of Breast Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital& Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

AI问答

⁰