| Eligibility |
Inclusion Criteria:
1. Voluntarily sign the written informed consent.
2. Breast cancer confirmed by histology or cytology and meeting the following conditions:
1. According to the breast cancer diagnosis and treatment guidelines (2022) of the
Chinese Society of Clinical Oncology (CSCO), the investigators judge the breast
cancer patients who are suitable for anti-tumor treatment with paclitaxel for
injection (albumin-bound) alone.
2. According to RECIST 1.1 standard, there is at least one measurable focus. For the
lesions that have been treated with radiotherapy in the past, the lesions can be
included in the measurable lesions only if the disease progression is clear after
radiotherapy.
3. Age = 18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days
before the first administration.
5. Expected survival time =3 months.
6. Normal function of main organs within 7 days before the first administration [no blood
transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or
other medical support treatment within 14 days before the first administration],
meeting the following criteria:
1. Absolute neutrophil count (ANC) = 1.5 × 10^9/L; Platelet count (PLT)= 100 ×
10^9/L; Hemoglobin (Hb) = 90 g/L.
2. AST?ALT = 10 × ULN; Total bilirubin (TBIL) = 1.5 × ULN; Serum creatinine = 1.5 ×
ULN and Creatinine clearance = 30 mL/min.
3. Activated partial thrombin time (APTT) /Prothrombin time (PT)/International
standardized ratio (INR)=1.5 × ULN.
7. The patients with fertility agreed to use reliable contraceptive measures (such as
intrauterine device [IUD], contraceptives or condoms) during the study period and
within 6 months after the end of the study; The serum pregnancy test of women of
childbearing age is negative within 7 days before the study enrollment.
Exclusion Criteria:
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 active brain metastasis without treatment (including symptomatic brain
metastasis or meningeal metastasis); If the brain metastasis of the patient has been
treated and the condition of the metastasis is stable (the brain imaging examination
at least 4 weeks before the first administration shows that the lesion is stable, and
there is no new nervous system symptom, or the nervous system symptom has returned to
the baseline level, and there is no need for hormone treatment at least 14 days before
the first administration of the investigational treatment), and there is no evidence
of new or original brain metastasis enlargement, the patient is allowed to be
enrolled.
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.
5. There are any of the following concomitant diseases:
1. Serious or uncontrolled cardiovascular diseases: such as chronic congestive heart
failure of grade ? or above (NYHA standard), uncontrolled hypertension (excluding
stable ones with systolic blood pressure>150 mmHg and/or diastolic blood
pressure>90 mmHg after stable treatment), etc.
2. There are clear neurological diseases (such as epilepsy, dementia, etc.) and =
grade 3 peripheral neuropathy.
3. Serious respiratory diseases, such as asthma requiring glucocorticoid drugs,
chronic obstructive pulmonary disease (acute exacerbation), etc.
4. Uncontrolled diabetes (fasting blood glucose = 10 mmol/L after stable treatment).
5. Serious chronic or active infection requiring systemic antibacterial, antifungal,
or antiviral treatment (such as anti-infective drugs have been used for more than
one week before the first administration and will continue to be used), including
tuberculosis infection, etc.
6. Active HBV (HBsAg positive patients need to be tested for HBV DNA, which will be
excluded if the HBV DNA is greater than the upper limit of the normal value) or
HCV infection (patients with polymerase chain reaction (PCR) HCV RNA within the
normal value range can participate in this study) or syphilis antibody positive
(and confirmed) or HIV positive.
7. Rash on any part of the body and any disease that may cause skin reactions, such
as cholestasis, systemic lupus erythematosus, eczema, allergic dermatitis, atopic
dermatitis, herpes zoster, psoriasis, etc.
6. Have the following previous medical history:
1. Major surgical operations (such as abdominal and thoracic major operations;
excluding minor operations such as diagnostic puncture or infusion device
implantation) have been performed within 28 days before the first administration
of the study treatment, or major surgical treatment is expected to be required
during the study period.
2. Serious cardio-cerebrovascular diseases occurred within 6 months before the first
administration, such as myocardial infarction, unstable angina pectoris,
cerebrovascular accident (lacunar cerebral infarction without clinical
significance can be included), etc.
7. The following previous/concomitant drugs or therapies exist:
1. Those who use glucocorticoids or antihistamines or other drugs with therapeutic
or preventive effects on rash within 2 weeks or 5 half-lives (whichever is
longer) before the first administration.
2. Those who need to be treated with other anti-tumor drugs during the study.
3. Vaccinated within 4 weeks before the first administration or expected to be
vaccinated during the study administration.
4. Those who are expected to undergo radiotherapy or hemodialysis within 2 months
after the first administration.
8. Patients who are pregnant, nursing or planning to become pregnant during the study.
9. Other situations in which the investigator judged that the patient was not suitable
for the study.
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