An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 Combination Therapy in Patients With Breast Cancer
This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
• Women aged 18-75 years.
• ECOG performance status 0-1.
• Menopausal status.
• Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration.
• At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria.
• Expected survival \> 3 months.
• Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.
• Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visits and procedures, understand the study procedures, and have signed the informed consent form.