This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR inhibitors in patients with ER+/HER2- locally advanced or metastatic breast cancer. The study consists of two stages: a Phase Ib dose-escalation stage and a Phase II dose-expansion stage.
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Safety and Tolerability (Phase Ib)
Timeframe: Throughout phase Ib (approximately 1 year)
Recommended phase II dose (RP2D) (Phase Ib)
Timeframe: Throughout phase Ib (approximately 1 year)
Objective Response Rate (ORR) (Phase II)
Timeframe: From time of Informed Consent to confirmed progressive disease (approximately 1 year)