Her2 positive breast cancer
Conditions
Interventions
Case series:Pyrotinib combined therapy
Sponsors
Changhai Hospital, Navy Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years; 2. Histologically confirmed HER2-positive local relapsed or metastatic breast cancer; 3. Recurrence/metastasisd after adjuvant anti-HER2 therapy or did not receive any systematic anti-tumor treatment (except first-line endocrine therapy or chemotherapy) for relapsed or metastatic disease; 4. Newly diagnosed stage IV HER2 positive advanced breast cancer; 5. ECOG performance status of 0-1; 6. Had measurable lesions; 7. The function of main organs must meet the following requirements (1) WBC >= 4.0 x 10^9/L; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count (PLT) >= 100 x 10^9/L; Haemoglobin (Hb) >= 90 g/L. (2) Chemistry: Total bilirubin (TBIL) = 50%. (4) 12-lead ECG:Fridericia-corrected QT interval (QTcF) <= 480 ms. (5) Being voluntary to participate in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. With a history of abuse of psychotropic drugs and can not quit or have mental disorders; 2. Other malignant tumors in the past 5 years, exception of cured carcinoma cervix in situ, basal cell or squamous cell carcinoma of skin; 3. Severe heart disease or discomfort; 4. Treatment in another clinical trial within the past 4 weeks before start of therapy; 5. Inability to swallow, bowel obstruction, or presence of other factors affecting drug intake and absorption; 6. Known history of allergy to the drug components in this protocol; 7. History of immunodeficiency disease, or history of organ transplantation; 8. Pregnant or lactating female patient, female patient with childbearing potential and positive pregnancy test at baseline, or the females of childbearing potential who are not willing to use effective contraceptive measures throughout the trial; 9. Did not recover to grade 0-1 from the toxicity of previous treatment (except hair loss); 10. Severe concurrent disease, or any other condition that is considered by investigators as unsuitable to participate in this study; 11. Any of the other conditions of which researchers believe that the patient is not fit to take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DoR;CBR;DCR;OS; | — |
Countries
China
Contacts
Public ContactYuan Sheng
Changhai Hospital, Navy Medical School
Outcome results
None listed