| Eligibility |
Inclusion Criteria:
1. Voluntarily participate in this study, sign an informed consent form, have good
compliance, and are willing to follow-up.
2. Female, aged = 18 and = 70 years, with an ECOG score of 0-1 and an expected survival
time of = 12 weeks.
3. The pathological and/or cytological diagnosis (based on the latest biopsy results) is
HER2 negative recurrent or metastatic breast cancer, regardless of hormone receptor
status (ER/PR positive or negative, but the hormone receptor status needs to be
determined);
4. All patients have received at least paclitaxel and/or anthracycline as a treatment
option;
5. All patients with prior treatment = 3 lines (for those who progress during the
neoadjuvant/adjuvant period or within 12 months after the end of the last treatment,
it is considered as the first line, and no progress is counted as the number of
lines); For HR+/HER2- breast cancer patients, they also need to have received the
first line systemic CDK4/6 inhibitor+endocrine therapy before the disease progresses.
6. According to RECIST 1.1 standard, there is at least one measurable extracranial lesion
present.
7. Within one week before enrollment, the blood routine examination was basically normal
(no blood transfusion within two weeks, no use of drugs to increase white blood cells
or platelets):
Neutrophil count (ANC) = 1.5 × 109/L; Platelet count (PLT) = 90 × 109/L; Hemoglobin =
9.0 g/dL.
8. Within one week before enrollment, the blood biochemistry test was basically normal
(based on the normal values of each research center laboratory): Total bilirubin
(TBIL) = 1.5 x Upper limit of normal value (ULN) SGPT/ALT = 3 × ULN (liver metastasis
patients = 5 × ULN); SGOT/AST = 3 × ULN (liver metastasis patients = 5 × ULN); The
creatinine clearance rate (Ccr) is = 50 ml/min (Cockcroft Gault formula).
9. No major organ dysfunction
10. Women with fertility must agree to use effective contraceptive methods during the
study period and within 6 months after the last study medication. Women with fertility
must have a negative blood or urine pregnancy test before enrollment.
Exclusion Criteria:
1. Other malignant tumors within the 5 years prior to enrollment, excluding cured
cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid
carcinoma without lymph node metastasis, or squamous cell carcinoma of the skin.
2. Those who meet the following conditions:
1. Received systemic anti-tumor therapy within 2 weeks prior to enrollment,
including but not limited to endocrine therapy, small molecule targeted therapy,
anti-tumor traditional Chinese medicine, etc;
2. Within the 4 weeks prior to enrollment, chemotherapy, targeted biological therapy
or immunotherapy, other clinical investigational drugs, radiation therapy, or
major organ surgery (excluding biopsy) or significant trauma have been received,
or elective surgery is required during the trial period. Those who have undergone
major surgeries;
3. Received nitroso urea or mitomycin C within 6 weeks prior to enrollment;
3. Individuals who have previously received treatment with Utidelone injection.
4. Peripheral neuropathy CTCAE 5.0 grade evaluation = 2.
5. Those who have received treatment with capecitabine or other drugs with an active
ingredient of 5-fluorouracil (excluding those who relapse after more than 12 months of
treatment).
6. Pregnant and lactating patients.
7. Adverse reactions from previous anti-tumor treatments have not yet recovered to CTCAE
5.0 grade =1 (excluding toxicity judged by researchers to have no safety risk for hair
loss).
8. Accompanied by meningeal metastasis; Accompanied by uncontrollable brain metastases
(researchers have determined that new asymptomatic brain metastases or those known to
have stable brain metastases after treatment can be enrolled); Or uncontrollable bone
metastasis, which refers to patients who have or have recently been at risk of
fractures or have obvious symptoms or other critical situations.
9. Uncontrollable pleural effusion, pericardial effusion, or abdominal effusion.
10. Individuals with active infections who currently require systematic anti infection
treatment.
11. Have a history of immunodeficiency, including HIV antibody testing positive, or have
other acquired or congenital immunodeficiency diseases, or have a history of organ
transplantation.
12. Individuals with active hepatitis B or hepatitis C; Known active syphilis infection.
13. Have a history of severe cardiovascular and cerebrovascular diseases, including but
not limited to:
Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias
requiring clinical intervention, grade II-III atrioventricular block, etc; At rest,
the average QTcF obtained from three 12 lead electrocardiogram examinations is>470ms;
Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other
Grade 3 or higher cardiovascular events occurring within 6 months prior to the first
administration; Hypertension that cannot be controlled clinically. Other researchers
have identified high-risk heart diseases.
14. Uncontrolled diabetes patients.
15. Patients with active gastrointestinal ulcers.
16. Have a clear history of neurological or psychiatric disorders, including epilepsy or
dementia.
17. Participate in another clinical trial or use other investigational treatments
simultaneously.
18. Individuals known to be allergic to the investigational drug or any of its excipients.
19. The researchers believe that the subjects have a history of other serious systemic
diseases or other reasons that make them unsuitable to participate in this trial.
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