TFX06

Phase I primary objective: To determine the recommended Phase II dose (RP2D) and potential effective therapeutic dose range of oral TFX06 for single daily administration. Secondary objectives: To evaluate the safety and tolerability of TFX06 tablets in patients with ER+/HER2- locally advanced or metastatic breast cancer. To evaluate the dose intensity and medication compliance of daily oral administration of TFX06 tablets. To describe the pharmacokinetic (PK) and pharmacodynamic characteristics (PD) of TFX06 tablets after oral administration. To preliminarily evaluate the anti-tumor effect of TFX06 tablets in patients with ER+/HER2- locally advanced or metastatic breast cancer. PFS and OS assessed by the investigator according to RECIST V1.1. Phase II primary objective: To further evaluate the anti-tumor effect of TFX06 tablets in patients with ER+/HER2- locally advanced or metastatic breast cancer by DCR (CR+PR+SD ≥12 weeks) assessed by the investigator according to RECIST V1.1. Secondary objectives: To further evaluate the anti-tumor effect of TFX06 tablets in patients with ER+/HER2- advanced breast cancer by PFS, OS, ORR, DoR, PFS rate at 3 months, 6 months and 12 months and DCR assessed by the investigator according to RECIST V1.1. To further evaluate the safety and tolerability of TFX06 tablets at the RP2D level.