Clinical trial NCT03085368: A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin
Official title: A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib and Paclitaxel vs Herceptin and Paclitaxel With Sequential and Synchronous Anthracycline
Conditions: HER2-positive Breast Cancer
Summary: This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline
Interventions:
description: Lapatinib produced by glaxosmithkline. Oral small molecule epidermal growth factor tyrosine kinase inhibitor. Mainly used for combined with capecitabine in the treatment of ErbB-2 over expression, including received prior anthracycline, paclitaxel and trastuzumab (Herceptin) in the treatment of advanced or metastatic breast cancer. Our clinical trial want to see its benefit in early breast cancer
name: lapatinib/herceptin
type: Drug
Study arms:
design_group_description: Epirubicin 80 mg/ IV day M2 Cyclophosphamide 600 mg/m2 day IV 21 days for a total of 1 cycles, with a total of 4 cycles sequential Docetaxel 100mg/m2 IV day 1 21 days for a total of 1 cycles, with a total of 4 cycles Lapatinib 1000mg/d Po (fasting) every 30 days for a cycle Note: lapatinib in the first injection of docetaxel drug taking, once a day, oral dose of 1000mg, a total of over 1 years;
design_group_title: EC→PL(Epirubicin+Cyclophosphamide--Docetaxel+lapatinib)
design_group_type: Experimental
design_group_description: 80mg/ M2 day 1 IV epirubicin Paclitaxel 150mg/m2 IV day 1 14 days for a total of 1 cycles (intensive chemotherapy), with a total of 6 cycles Also given Lapatinib 1000mg/d Po (fasting) every 30 days for a cycle Note: lapatinib in the first injection of paclitaxel drug taking, once a day, oral dose of 1000mg, a total of over 1 years;
design_group_title: PEL(Paclitaxel+epirubicin+Lapatinib)
design_group_type: Experimental
design_group_description: Table 80mg/ day 1 IV Cyclophosphamide 600 mg/m2 day IV 21 days for a total of 1 cycles, with a total of 4 cycles Docetaxel 100mg/m2 IV day 1 21 days for a total of 1 cycles, with a total of 4 cycles Trastuzumab 2mg/kg IV QW (first dose 4 mg/kg) Note: trastuzumab was administered at the beginning of the first injection of paclitaxel, with an injection dose of 2mg/kg, 1 times a week, for a total of up to 1 years; followed by trastuzumab 2mg/kg IV, once every 3 weeks for a total of one year
design_group_title: EC→PH(Epirubicin+Cyclophosphamide--Docetaxel+herceptin)
design_group_type: Active Comparator
design_group_description: 80mg/ M2 day 1 IV epirubicin Paclitaxel 150mg/m2 IV day 1 14 days for a total of 1 cycles, with a total of 6 cycles Also given Trastuzumab 2mg/kg IV QW (first dose 4 mg/kg) Note: trastuzumab was administered at the beginning of the first injection of paclitaxel, with an injection dose of 2mg/kg, 1 times a week, for a total of up to 1 years; followed by trastuzumab 2mg/kg IV, once every 3 weeks for a total of one year
design_group_title: EPH(Paclitaxel+epirubicin+herceptin)
design_group_type: Active Comparator
Sponsor: Peking Union Medical College Hospital
Collaborators: EOC Pharma (Thaizhou) Co., Ltd.
Drug name mappings:
name: 曲妥珠单抗
lang: CN
name: Trastuzumab
lang: EN
name: トラスツズマブ（遺伝子組換え）
lang: JP
name: 二甲苯磺酸拉帕替尼
lang: CN
name: Lapatinib Ditosylate Hydrate
lang: EN