This is a randomized, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of HB1801 compared with Taxotere® in patients with advanced breast cancer. A total of 60 subjects with advanced breast cancer are planned to be enrolled.The trial consists of three phases: screening period, open-label treatment period, and follow-up period. HB1801 is Docetaxel for injection (Albumin-bound).
1. Age ≥ 18 years old (based on the date of signing the informed consent form).
2. Voluntarily participate in this clinical trial, sign the informed consent form, and be willing and able to adhere to the treatment, visits, and related procedures specified in the protocol.
3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer, meeting the following criteria: a) The investigator determines that the patient is suitable for single-agent docetaxel treatment, in accordance with the 2025 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Treatment Guidelines. b) At least one measurable lesion according to RECIST 1.1 criteria. For lesions previously treated with radiotherapy, the lesion can only be included as a measurable lesion if clear disease progression occurs after radiotherapy.
4. Within 7 days before randomization, major organ/system functions are basically normal, meeting the criteria as assessed by laboratory tests.
1. Prior treatment with docetaxel monotherapy or combination therapy for unresectable locally advanced or metastatic breast cancer.
2. Subjects with partially or completely intestinal obstruction that cannot be relieved by active treatment; history of inflammatory bowel disease, chronic diarrhea, or gastrointestinal bleeding.
3. Known severe allergic history or hypersensitivity (NCI-CTCAE v5.0, ≥ grade 3) to human albumin or docetaxel, and/or contraindications; known severe allergic history and/or contraindications to glucocorticoids (including but not limited to active peptic ulcer, severe hypertension, severe hypokalemia, glaucoma, etc.).
4. Untreated active brain metastases (including symptomatic brain metastases or leptomeningeal metastases); subjects with treated brain metastases are eligible if the metastatic lesions are stable (brain imaging demonstrates stability for at least 4 weeks before randomization, no new neurological symptoms or neurological symptoms have returned to baseline, and no hormonal therapy is required for at least 14 days before randomization for investigational treatment), and there is no evidence of new or enlarged pre-existing brain metastases.