A randomized Phase I/II trial of fulvestrant and abemaciclib in combination with copanlisib (FAC) versus fulvestrant and abemaciclib alone (FA) for endocrine-resistant hormone receptor positive HER2 negative metastatic breast cancer (FAC vs FA)

Brief description of study

The purpose of the study is to determine the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative stage IV breast cancer. Abemaciclib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. We want to know if adding copanlisib to the usual therapy of fulvestrant and abemaciclib may work better than giving fulvestrant and abemaciclib alone in treating patients with breast cancer. The study drug copanlisib is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.




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