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[1] Úùê»,ÂÀÇà.È«Çò¼°ÖйúÈéÏÙ°©µÄÊ¢Ðв¡Ñ§Ç÷ÊÆ¼°·À¿ØÆôʾ£º£º2018–2022Äê¡¶È«Çò°©Ö¢Í³¼Æ±¨¸æ¡·½â¶Á[J].ÖйúÆÕÍâ»ù´¡ÓëÁÙ´²ÔÓÖ¾,2024,31(07):796-802.
[2] National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline).Breast Cancer, version 5. 2023[EB/OL]. [2024-01-12].
[3] ÖйúÁÙ´²Ö×Áöѧ»áÖ¸ÄÏÊÂÇéίԱ»á,±àÖø.ÖйúÁÙ´²Ö×Áöѧ»áÈéÏÙ°©ÕïÁÆÖ¸ÄÏ 2024[M].±±¾©:ÈËÃñÎÀÉú³öÊéÉç.
[4] Xu Z, Liu Y, Song B, et al. Discovery and preclinical evaluations of TQB3616, a novel CDK4-biased inhibitor. Bioorganic & Medicinal Chemistry Letters 2024; 107.
[5] TQB3616ÁªºÏ·úά˾ȺÖÎÁƼ¤ËØÊÜÌåÑôÐÔ¡¢¡¢HER2ÒõÐÔÍíÆÚÈéÏÙ°©£º£ºÒ»ÏîËæ»ú¡¢¡¢Ë«Ã¤¡¢¡¢Æ½ÐбÈÕÕµÄ3ÆÚÁÙ´²ÊÔÑ飬2024 CSCO£¬9ÔÂ27ÈÕÁ¢Òìר³¡.
[6] Erwei song, et al. Culmerciclib plus fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer cancer:A phase 3 trial(CULMINATE-2),ESMO 2025 LBA25.
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