A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer

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.

NCT Number	NCT07173556
Lead Sponsor	Qilu Pharmaceutical Co., Ltd.
Conditions	Advanced Breast Cancer
Enrollment	96 participants
Start Date	2025-09
Primary Completion	2027-02 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2025-09-15