| Eligibility |
Inclusion Criteria:
- Women =18 years old and =70 years old.
- ECOG body status level 0 ~ 1.
- The expected survival is not less than 3 months.
- Breast cancer patients with histologically proven invasive triple-negative breast
cancer (specifically defined as estrogen receptor (ER), progesterone receptor (PR) and
human epidermal growth factor receptor 2 (HER-2) who are all negative by pathological
tests. Specifically: ER negative: IHC<1%, PR negative: IHC<1%, HER2 negative: IHC-/+
or IHC++ but FISH/CISH negative. All specimens should be verified by the pathology
department of the research center, and the molecular typing of relapses and metastases
should be re-checked.
- Tumor stage: recurrent or metastatic breast cancer; Patients with local recurrence
need to be confirmed by the investigator that radical surgical resection is not
possible.
- Stage II: patients who have not used paclitaxel or have used paclitaxel in
adjuvant/neoadjuvant therapy, but the interval from the end of treatment to relapse is
greater than 6 months; No systemic anti-tumor therapy (chemotherapy, targeted therapy,
etc.) has been received in the advanced stage.
- Stage I: The advanced stage has received =1 line systemic anti-tumor therapy
(chemotherapy, targeted therapy, etc.).
- Have at least one measurable lesion or unmeasurable lesion according to RECIST version
1.1 (measurable lesion =20mm conventional CT scan and =10mm spiral CT scan, measurable
lesion not receiving radiotherapy).
- The functions of the main organs are basically normal.
- Have not received radiotherapy, endocrine therapy, molecular targeted therapy, or
surgery (except for procedures unrelated to antitumor therapy such as central venous
catheterization) within 3 weeks prior to the start of the study, and have recovered
from acute toxic effects of previous treatment (if surgery is available, the wound has
fully healed).
- No peripheral neuropathy or grade I peripheral neurotoxicity.
- Fertile female subjects are required to use a medically approved contraceptive during
study treatment and for at least 3 months after the last use of the study drug; The
subjects voluntarily joined the study, signed informed consent, had good compliance,
and cooperated with follow-up.
Exclusion Criteria:
- Stage II: patients with adjuvant/neoadjuvant use of paclitaxel but the interval from
the end of taxol treatment to recurrence and metastasis is less than 6 months, or have
received systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) in the
late stage;
- Stage I: no systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has
been received in the advanced stage;
- Patients with known central nervous system metastasis or history of central nervous
system metastasis prior to screening. For patients with clinically suspected central
nervous system metastasis, enhanced CT or enhanced Magnetic Resonance Imaging (MRI)
must be performed within 28 days before the first dose to rule out central nervous
system metastasis.
- A history of clinically significant or uncontrolled heart disease, including
congestive heart failure, angina pectoris, myocardial infarction within the last 6
months, or ventricular arrhythmia;
- Persistent grade =1 adverse events due to previous treatment. The exception to this is
hair loss or something the researchers believe should not be ruled out. Such cases
should be clearly documented in the investigator's notes;
- Major surgery was performed within 3 weeks of the first course of trial treatment
(except for minor outpatient surgery, such as placement of vascular access);
- Pregnant or lactating patients;
- Other malignancies within the previous 5 years, excluding cured cervical carcinoma in
situ, skin basal cell carcinoma, or skin squamous cell carcinoma.
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple
factors that affect drug use and absorption;
- There is a third space effusion that cannot be controlled by drainage or other methods
(such as excessive pleural fluid and ascites);
- Participated in clinical trials of other antitumor drugs within 4 weeks before taking
the study drug for the first time;
- long-term unhealed wounds or incomplete healing fractures;
- Patients with known HBV or HCV infection active phase or hepatitis B DNA=500, or
chronic phase with abnormal liver function;
- Allergic physique, or known allergic history of the drug components of this program;
Or allergic to other monoclonal antibodies;
- Malignant tumors within the past five years (except for cured basal cell carcinoma of
the skin and carcinoma in situ of the cervix).
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