breast cancer
Conditions
Interventions
Experimental group:trastuzumab and pyrrolitinib
Sponsors
Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The primary tumor tissue is HER2 amplification-negative recurrent or distant metastatic breast cancer, as well as newly diagnosed stage IV HER2 amplification-negative breast cancer patients; all enrolled patients have received >= second-line therapy before; Note: Negative HER2 expression refers to the primary tumor tissue detected by IHC/FISH (clinical report), and the cell immunohistochemical staining intensity is 0, 1+ or 2+ but the fluorescence in situ hybridization (FISH) confirmed negative; 2. Aged 18-75 years, female; 3. Good physical strength: ECOG score 0-1; 4. The expected survival period is more than 3 months; 5. The patient has no major organ dysfunction; including: (1) Blood routine: ANC>=1.5x10^9/L; PLT>=90x10^9/L; Hb>=90 g/L; (2) Blood biochemistry: TBIL=50 mL/min (Cockcroft-Gault formula); (3) Echocardiography: LVEF>=50%; 12-lead ECG-corrected QT interval (QTcF) by Fridericia method < 450 ms for males and < 470 ms for females. 6. According to RECIST 1.1 criteria, there are evaluable tumor lesions; 7. Voluntarily join the group, agree and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have received anti-HER2 treatment in the past, or who have received research drugs or preparations/treatments within 4 weeks before enrollment (ie, participating in other trials); 2. Patients who are allergic to the study drug or unable to take the drug orally; patients who refuse the drug regimen; 3. Patients with other malignant tumors, except for cured non-melanoma skin cancer, cervical carcinoma in situ and other tumors that have been cured for at least 5 years; 4. Patients who are pregnant or breastfeeding (pregnancy tests are required for women of childbearing age), female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial ; 5. In the active period of other acute infectious diseases or chronic infectious diseases; 6. History of uncontrolled epilepsy, central nervous system disease or mental disorder; 7. Patients with impaired consciousness and others without legal capacity or limited legal capacity; 8. Known history of human immunodeficiency virus; 9. Other conditions in which the researcher believes that the patient should not participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate, RR;Progression free survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactYuan Peng
Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed