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

Exclusion Criteria

• •Presence of symptomatic visceral disease or any other condition deemed unsuitable for endocrine therapy as per the investigator's judgment.
• •Presence of unresolved toxicities from prior therapy that have not recovered to ≤ CTCAE grade 1, excluding alopecia (any grade) or other toxicities considered by the investigator to pose no safety risk.
• •Received anti-tumor drug therapy within the specified time window prior to the first dose of the investigational drug.
• •Prior treatment with an experimental SERD or experimental ER antagonist.
• •Received radiotherapy within 4 weeks prior to the first dose of the investigational drug.
• •Used a strong CYP3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first dose.
• •Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has not recovered from significant side effects, or has significant traumatic injury, non-healing wounds, or fractures.
• •History of other active malignancies within 5 years prior to the first dose of the investigational drug.
• •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• •Inability to swallow the formulation, or gastrointestinal impairment/disease that may affect adequate absorption of the investigational drug.
• •Known clinically significant liver disease, including Child-Pugh class B or C, active viral hepatitis, or other hepatitis.
• •Current documented grade 1 or higher pneumonitis or interstitial lung disease.
• •Clinically significant pleural effusion, ascites, or pericardial effusion, defined as detectable on examination and requiring drainage within the past 2 weeks or additional medication to control symptoms.
• •Clinically significant uncontrolled cardiac disease and/or recent cardiac events.
• •History of bleeding tendency, thrombosis, or tumor embolism.
• •Planned treatment with everolimus and presence of uncontrolled diabetes despite adequate therapy.
• •Allergy to any of the investigational medicinal products or their components.