breast cancer
Conditions
Interventions
Case series:Pyrotinib Maleate combined with chemotherapy
Sponsors
Guizhou Provincial Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects met all of the following criteria for inclusion in the study: 1. Patients with advanced recurrent/metastatic breast cancer confirmed by pathology or imaging examination; 2. Breast cancer patients with HER2 positive, low HR (1%-9%) or HR- determined by immunohistochemistry or fluorescence in situ hybridization; 3. Women aged 18 to 70 years old; 4. KPS score = 70; 5. Have at least one measurable lesion according to the RECIST version 1.1 standard; 6. The expected survival period is =3 months; 7. The functional level of the main organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes, platelet-up drugs): (1) Blood routine: Hb=90 g/L; ANC = 1.5 × 10^9/L; PLT=75×10^9/L; (2) Blood biochemistry: TBIL=1.5×ULN; ALT and AST = 2 × ULN; if there is liver metastasis, ALT and AST = 5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) = 1.5 × ULN; (3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) = 50%; (4) 12-lead ECG: The QT interval (QTcF) corrected by the Fridericia method is < 470 msec; 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug; 9. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: Subjects were not included in the study in any of the following circumstances: 1. Pregnant or lactating women; 2. Previously treated with pyrrolidine maleate; 3. Received chemotherapy, targeted therapy or test drug within 2 weeks prior to enrollment; received endocrine therapy within the first 7 days (except for local reduction therapy, such as radiotherapy for relieving bone pain); 4. There is a third interstitial fluid (such as chest, ascites, pericardial effusion) that cannot be controlled by drainage or other parties; 5. Unable to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug; 6. Those with allergies, or those who are known to have a history of drug components of this program; immunodeficiency diseases include positive HIV test, or history of organ transplantation with other acquired, innate immune deficiency diseases; 7. Have had other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cells or squamous cell carcinoma of the skin; 8. The patient has physical or mental illness and the investigator believes that the patient is unable to fully or fully understand the possible complications of the study, or has no civil capacity or limited capacity for civil conduct; 9. The patient has a severe concomitant disease, an uncontrollable medical condition, or any other condition the investigator believes is inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;QoL;DoR;CBR; | — |
Countries
China
Contacts
Public ContactRan Li
Guizhou Medical University
Outcome results
None listed