Breast Cancer
Conditions
Interventions
test group:Pyrrotinib combined with oral vinorelbine beat therapy
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
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 reviewed and confirmed). 5. Disease progression occurs 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 phase = 10 mm (CT scan thickness not greater than 5 mm)] and who have progressed after or during the last anti-tumor treatment (RECIST Version 1.1); 8. The main organs function 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 x 10^9 /L; PLT >= 75 x 10^9 /L; 2) Biochemical inspection must meet the following standards: TBIL = 50ml/min (based on Cockroft and Gault formula); 3) Heart ultrasound Left ventricular ejection fraction (LVEF) >= 50%; 9. For female patients who have not undergone menopause or have not undergone surgical sterilization: during the treatment period and at least 7 months after the last administration in the study treatment, agree to abstain from sex or use an effective method of contraception. 10. Patients voluntarily join the study, have good compliance with the planned treatment, understand the research process of this study and sign a written informed consent form.
Exclusion criteria
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: (1)Confirmed history of heart failure or systolic dysfunction (LVEF 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) (1)Angina pectoris that requires antiangina medication (2)Clinically significant heart valve disease (3)ECG shows transmural myocardial infarction (4)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 tests, 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;QoL;Security (CTCAE 5.0); | — |
Countries
China
Contacts
Public ContactChunfang Hao
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed