Breast cancer
Conditions
Interventions
1:taking abecicilb
Sponsors
The Fifth Affiliated Hospital, Sun Yet-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed histopathologically confirmed locally advanced or metastatic hormone receptor-positive (estrogen receptor ER and/or progesterone receptor PR-positive) and HER2-negative (human epidermal growth factor 2 ( HER2) expression deficiency), patients who are not suitable for surgical treatment; 2. Received first-line or above systemic therapy in the past, with disease progression after the last treatment, and have used anthracyclines and/or taxanes, and currently there is no standard treatment plan; 3. Must have at least one evaluable lesion according to RRECIST version 1.1 criteria (the longest diameter on spiral CT is at least 10mm, and the longest diameter on ordinary CT is at least 20mm); 4. Female, aged >= 18 years old and = 3 months; 7. Sufficient blood function: absolute neutrophil count (ANC) >= 1.5 x 10^9/L and platelet count >= 80×10^9/L and hemoglobin >= 8g/dL; 8. Sufficient liver function: total bilirubin >= 1.5 times the upper limit of normal (ULN); AST and ALT = 50 mL/min; 10. The electrocardiogram is basically normal; 11. Women with an intact uterus must have a negative pregnancy test result within 28 days prior to enrollment in the study (unless it has been 24 months of amenorrhea). If the pregnancy test is more than 7 days from the first dose, a urine pregnancy test is required for verification (within 7 days before the first dose); 12. Have not received radiotherapy, chemotherapy, targeted therapy and other treatments within 4 weeks before enrollment; 13. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women, or female patients who are fertile but not taking contraceptive measures; 2. Existing severe acute infection that has not been controlled; or purulent and chronic infection with persistent wound healing; 3. Patients with original serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease and resistant hypertension; 4. Those with bleeding tendency; 5. People with mental disorders/people who cannot obtain informed consent; 6. Patients who use drugs and alcohol for a long time, which affects the evaluation of the test results; 7. Other conditions in which the investigator believes that the patient should not participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;safety assessment; | — |
Countries
??
Contacts
Public ContactPeijian Peng
The Fifth Affiliated Hospital, Sun Yet-sen University
Outcome results
None listed