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[高分] HER2 Targeted Therapy with Dalpiciclib and AI Versus with Chemotherapy in HR+HER2+ Local Recurrent or Metastatic Breast Cancer: a Multicentre, Open-Label, Randomised Phase 2 Trial
HER2靶向治疗HR+HER2+局部复发或转移性乳腺癌与化疗的比较：一项多中心、开放标签、随机2期试验
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| 其它 | INTERVENTION: Experimental group1:trastuzumab +pertuzumab + aromatase inhibitor + dalpiciclib;Experimental group2:trastuzumab +pertuzumab + aromatase inhibitor;Control Group:trastuzumab +pertuzumab+taxanes ; CONDITION: Breast Cancer PRIMARY OUTCOME: Progression‐free survival; SECONDARY OUTCOME: overall survival;Objective remission rate;Disease control rate;Clinical benefit rate;Safety;Quality of life score; INCLUSION CRITERIA: 1.Local recurrent or metastatic HR+HER2+ breast cancer diagnosed by imaging and pathology; 2.Female, age >= 18 years old; 3.The local laboratory evaluates primary or metastatic tumors as HER2 positive, which is defined as the immunohistochemical of HER2 is 3 + or the fluorescence in situ hybridization (FISH) is +; 4.The local laboratory evaluates primary or metastatic tumors as hormone receptor positive, requiring ER >= 10% and PR >= 10%; 5.Not suitable for radical resection or radiotherapy |
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