Albumin-Bound Paclitaxel (Ⅱ) in Patients With Advanced Breast Cancer

Prior treatment

• Concurrent participation in other interventional clinical studies;

Other illness

• Known hypersensitivity or intolerance to study drugs or their excipients;
• History of malignancies other than breast cancer within 5 years prior to the first study drug dose, except for cured malignancies such as in-situ carcinoma and basal-cell carcinoma;

Other

• Uncontrolled third-space effusions (e.g., massive pleural, peritoneal, pericardial effusion) that cannot be stabilized (i.e., no further intervention required after drainage). Patients with small, asymptomatic pleural or peritoneal effusions identified by imaging are permitted;
• Active brain metastases (including symptomatic brain metastases or leptomeningeal metastases).

• Aged ≥ 18 years;
• Histologically and/or cytologically confirmed HER2-negative recurrent or metastatic breast cancer (HER2-negative subtype includes HR-positive HER2-negative and triple-negative breast cancer);
• No restrictions on prior lines or regimens for recurrent/metastatic disease (e.g., endocrine therapy, CDK4/6 inhibitors, ADC agents, chemotherapy, immunotherapy, etc.). For patients previously exposed to taxane-based therapy in the neoadjuvant, adjuvant, or metastatic-disease setting, recurrence or disease progression must have occurred \> 12 months after the last taxane administration;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• At least one measurable lesion per RECIST version 1.1. Patients with bone-only metastases without measurable lesions are eligible;
• Planned to receive monotherapy or combination regimens containing either Paclitaxel for Injection (Albumin Bound) (Ⅱ) or paclitaxel for injection (albumin-bound). Combination partners include, but are not limited to, PD-1 inhibitors, capecitabine, gemcitabine, cisplatin, and carboplatin;
• Fully informed and voluntarily provides written informed consent for study participation.