Objective To assess the efficacy and safety of pyrotinib (an irreversible pan-HER (human epidermal growth factor receptor) inhibitor), trastuzumab, and docetaxel compared with placebo, trastuzumab, and docetaxel for untreated HER2 positive metastatic breast cancer.
Design Randomised, double blind, placebo controlled, multicentre, phase 3 trial.
Setting 40 centres in China between 6 May 2019 and 17 January 2022.
Participants 590 female patients (median age 52 (interquartile range 46-58) years) with untreated HER2 positive metastatic breast cancer.
Interventions Eligible patients were randomised 1:1 to receive either oral pyrotinib (400 mg once daily) or placebo, both combined with intravenous trastuzumab (8 mg/kg in cycle 1 and 6 mg/kg in subsequent cycles) and docetaxel (75 mg/m2) on day 1 of each 21 day cycle. Randomisation was stratified by treatment history of trastuzumab in the (neo)adjuvant setting and hormone receptor status. Patients, investigators, and the sponsor’s study
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Munshi Ram, an 84-year-old resident of Udhampur, Jammu and Kashmir, has transformed a regular bicycle into an eco-friendly E-cycle powered by solar and electricity. Inspired by the Prime Minister s "Vocal for Local" and "Green India" initiatives, he used discarded laptop batteries and e-waste to build his E-cycle.
Operator: Good day and thank you for standing by. Welcome to the Coherus Biosciences Second Quarter 2023 Conference Call. At this time all participants are in a listen-only mode.
Coherus BioSciences Inc said on Wednesday that the U.S. Food and Drug Administration had flagged three observations at its partner s manufacturing site in China when the agency was conducting. | May 31, 2023