HER2-positive breast cancer with brain metastases
Conditions
Interventions
Case series:pyrrolidine combined + standard treatment plan
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure; 2. Women aged at least 18 years old; 3. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2; 4. HER2-positive breast cancer identified by immunohistochemistry or fluorescence in situ hybridization; 5. According to RECIST version 1.1 (see appendix), there is at least one intracranial measurable lesion larger than 10 mm; 6. Estimated survival (> 3 months); 7. The functional level of the main organs must meet the following requirements (no blood transfusion or drugs for raising white blood cells or platelets were used in the first 2 weeks of screening): 1) blood routine: neutrophils (ANC) greater than or equal to 1.5 x 10^9/L; Platelet count (PLT) greater than or equal to 90 x 10^9/L;Hemoglobin (Hb) is greater than or equal to 90 g/L; 2) blood biochemistry: total bilirubin (TBIL) is less than or equal to the upper limit of normal value (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than or equal to 1.5 * ULN.Alkaline phosphatase is less than or equal to 2.5 times ULN;Urea nitrogen (BUN) and creatinine (Cr) less than or equal to 1.5 * ULN; 3) cardiac color doppler ultrasound: LVEF is greater than or equal to 55%; 4) 12-lead ecg: the QT interval (QTcF) < 470 msec corrected by Fridericia method; 8. Women of childbearing age must have reliable contraceptive measures or in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last for 8 weeks after experimental drug using appropriate methods of contraception.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with single brain metastases who can be operated on; 3. Previous treatment with pyrrolidine maleate; 4. Received chemotherapy, targeted therapy or experimental drugs in the first two weeks, and endocrine therapy in the first seven days; 5. There is a third space effusion (e.g. pleural effusion and ascites) that cannot be controlled by drainage or other parties; 6. Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption; 7. People with allergic constitution or known history of drug components of this program; immunodeficiency disorders include HIV positive test, or other acquired and congenital immunodeficiency disorders with organ transplantation history; 8. Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin; 9. The patient has a serious concomitant disease, or any other condition that the researcher considers unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP;time to radiotherapy;ORR;safety; | — |
Countries
China
Contacts
Public ContactShu Zhao
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed