The main purpose of this study is to evaluate the efficacy and safety in subjects with advanced breast cancer treated with SYHX2011
1.Voluntarily sign the written informed consent and willing to cooperate with the research according to the requirements of the plan.
According to the breast cancer diagnosis and treatment guidelines (2022) of the Chinese Society of Clinical Oncology (CSCO), the breast cancer patients who are suitable for anti-tumor treatment with paclitaxel for injection (albumin-bound) alone judged by the investigators.
According to RECIST 1.1 standard, there is at least one measurable lesion. For the lesions that have been treated with radiotherapy in the past, only if the disease progression is clear after radiotherapy, then the lesions can be included as the measurable lesions.
3. Age ≥ 18 years.
1. History of severe allergy or major hypersensitivity to paclitaxel or human serum albumin (NCI-CTCAE Version 5.0, ≥ Level 3).
2. The toxicity of previous anti-tumor treatment has not recovered (NCI-CTC AE 5.0, >Level 1); Skin reaction or other hypersensitivity caused by any reason does not return to normal.
3. Patients with symptomatic brain metastasis or meningeal metastasis, or there is any evidence that shows uncontrolled brain metastasis or meningeal metastasis.
4. History of malignant tumors other than breast cancer within 5 years before the first administration, except for tumors that have recovered after treatment, such as carcinoma in situ, basal cell carcinoma, etc.
Single group
SYHX2011
DrugIV infusion, 260 mg/m\^2
Objective Response Rate (ORR) by Investigator
Progression-Free-Survival (PFS)
Time to progression (TTP)
Incidence of adverse events
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