| Eligibility |
Inclusion Criteria:
1. Age: 18-75 years old female patients;
2. The results showed that HER-2 was positive at least once in patients with recurrent
and metastatic breast cancer confirmed by pathology: HER-2 (+ + +) was confirmed by
immunohistochemistry; if HER-2 (+ +), fish / CISH was required to confirm HER-2
amplification;
3. Previous treatment (including neoadjuvant, adjuvant and rescue therapy) received at
least trastuzumab and TKIs;
4. It is allowed that the previous rescue chemotherapy does not exceed 3 lines, and must
be disease progression before being included in the study; it is allowed to receive
rescue endocrine therapy; chemotherapy allows to receive one of the chemotherapy of
albumin binding paclitaxel, vinorelbine, gemcitabine, capecitabine and aribrin;
5. At least one target lesion can be defined according to RECIST 1.1, and the target
lesion has not received radiotherapy (or other local treatment), unless it progresses
after the treatment;
6. Before the study, chemotherapy and targeted therapy must be completed for at least 2
weeks, and endocrine therapy and antiangiogenic drug treatment for 1 week;
7. ECoG PS: 0-1 points;
8. The expected survival time was more than 3 months;
9. The function of the main organs is normal, that is to say, it meets the following
standards:
1)Blood routine examination standard should meet (no blood transfusion and blood products
within 14 days, not used G-CSF and other hematopoietic stimulating factors were corrected)
- Hb=90g/L;
?ANC=1.5×109/L;
?PLT=75×109/L; 2)Biochemical examination should meet the following standards:
- TBIL<1.5×ULN;
- Alt, AST < 2.5 × ULN, liver metastasis < 5 × ULN;
- Bun and Cr = 1 × ULN or creatinine clearance rate = 50ml / min (Cockcroft
Gault formula).
10.Women of childbearing age must have a pregnancy test (serum) within 7
days before enrollment, and the results are negative, and they are willing
to use appropriate contraceptive methods during the trial and within 8 weeks
after the last administration of the trial drug; 11.The subjects volunteered
to join the study, signed the informed consent form, had good compliance and
cooperated with the follow-up.
Exclusion Criteria:
1. Symptomatic, uncontrolled brain metastases or leptomeningeal metastases.However,
patients with stable condition after local treatment for 4 weeks could be enrolled;
2. There was effusion in the third space which could not be controlled by drainage or air
pressure;
3. Interstitial lung disease, non-infectious pneumonia, memory pneumonia, pulmonary
fibrosis and other diseases;
4. Those who have a history of live attenuated vaccine vaccination in the 28 days before
the first study medication or are expected to receive live attenuated vaccine in the
study;
5. Other malignant tumors in the past 3 years, excluding cervical carcinoma in situ,
basal cell carcinoma of skin or squamous cell carcinoma of skin;
6. Patients with hypertension who could not be reduced to normal range after
antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood
pressure > 90 mmHg);
7. Suffering from serious or uncontrollable diseases, including but not limited to:
1) Active viral infection, such as HIV, HBV active phase (HBsAg positive and HBV-DNA = 103,
hepatitis C antibody positive); 2) Previous severe cardiovascular diseases: uncontrollable
hypertension; myocardial infarction, unstable arrhythmia, congestive heart failure,
pericarditis, myocarditis, etc. in the first six and six patients; according to NYHA
standard, grade III ~ IV cardiac insufficiency, or left ventricular ejection fraction
(LVEF) < 50% according to NYHA standard; 8.Patients with a history of psychotropic
substance abuse and unable to quit or with mental disorders; 9.According to the judgment of
the researchers, there are other patients with accompanying diseases that seriously
endanger the safety of patients or affect patients to complete the study; 10.Pregnant or
lactating women; 11.The researchers think it is not suitable for the participants.
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