| Eligibility |
Inclusion Criteria:
1. Female patients between 18 and 75 years old;
2. ECOG physical status score 0-2 points;
3. The expected overall survival period is not less than 12 weeks;
4. Pathologically confirmed HER2 expression-positive recurrent/metastatic breast cancer
patients; the standard for HER2 expression positive is immunohistochemical staining
(IHC) detection of HER2 3+ and/or fluorescent in situ hybridization (FISH) positive
The researcher of the test center reviews and confirms).
5. The disease progresses during or after treatment with trastuzumab (stopping the drug
for less than 12 months);
6. The number of chemotherapy lines used in the recurrence/metastasis stage is less than
or equal to 2 lines;
7. Patients who have at least one measurable lesion [spiral CT scan =10 mm (CT scan
thickness not greater than 5mm)] and who have progressed after or during the last
anti-tumor treatment (RECIST version 1.1);
8. The main organs are functioning normally, that is, they meet the following standards:
1) The standard of routine blood examination should meet: Hb=100 g/L (no blood transfusion
within 14 days); ANC=1.5×109 /L; PLT=75×109 /L; 2) The biochemical inspection shall meet
the following standards: TBIL=1.5×ULN (upper limit of normal value); ALT and AST=2.5×ULN;
if there is liver metastasis, ALT and AST=5×ULN; Serum creatinine =1.5×ULN, creatinine
clearance =50ml/min (based on Cockroft and Gault formula); 3) Heart color Doppler
ultrasound Left ventricular ejection fraction (LVEF) =50%; 9. For female patients who have
not undergone menopause or have not undergone surgical sterilization: during treatment and
at least 7 months after the last dose in the study treatment, agree to abstain from sex or
use an effective method of contraception. 10. Patients voluntarily join this study, have
good compliance with the planned treatment, understand the research process of this study,
and sign written informed consent.
Exclusion Criteria:
1. There is fluid in the third space that cannot be controlled by drainage or other
methods, such as pleural fluid and ascites;
2. There are many factors that affect the oral and absorption of drugs (such as inability
to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction,
etc.);
3. Severe heart disease or discomfort, including but not limited to the following
diseases:
- Confirmed history of heart failure or systolic dysfunction (LVEF <50%)
- High-risk uncontrolled arrhythmia, such as atrial tachycardia, resting heart
rate> 100 bpm, significant ventricular arrhythmia (such as ventricular
tachycardia) or higher grade atrioventricular block (ie Mobitz II second degree
atrioventricular block or third degree atrioventricular block)
- Angina pectoris that requires anti-angina pectoris medication
- Clinically significant heart valve disease
- ECG shows transmural myocardial infarction -Poor hypertension control (systolic
blood pressure> 180 mmHg and/or diastolic blood pressure> 100 mmHg).
4. Those who have been confirmed to be allergic to the drug components of this program;
have a history of immunodeficiency, including positive HIV testing, or have other
acquired or congenital immunodeficiency diseases, or have a history of organ
transplantation.
5. Patients who are known to be pregnant or planning to become pregnant, or patients of
gestational age who are unwilling to take effective contraceptive measures during the
entire trial period;
6. Suffer from serious concomitant diseases, such as infectious diseases.
7. Other malignant tumors have occurred in the past 5 years, except for cured cervical
carcinoma in situ and non-melanoma skin cancer;
8. Patients who have participated in other experimental studies within 30 days before the
first dose of study drug is administered;
9. Patients judged by the investigator to be unsuitable to participate in this study.
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