breast cancer
Conditions
Interventions
Case series:lapatinib+trastuzumab+Mono-chemotherapy
Sponsors
First People's Hospital of Foshan
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. 2. Aged 18 to 75 years; 3. Local recurrence or metastatic breast cancer(Initial stage IV patients may be enrolled) 4. HER2 was positive for breast cancer(Definition: IHC 3+; IHC 2+ and FISH positive) 5. ECOG PS 0/1 6. The baseline LVEF is greater than or equal to 50% at random 42 days. 7. In the past, no advanced first-line anti-tumor therapy or HER2 treatment was accepted, and the postoperative adjuvant trastuzumab was more than 12 months after treatment. 8. Normal laboratory values: blood function neutrophil count=1.5×10^9/L; blood platelet count=100×10^9/L; hemoglobin=9 g/dL; liver function total bilirubin=ULN; AST and ALT=3×ULN (no liver metastasis); AST and ALT = 5×UNL (liver metastasis); renal function: creatinine=1.5×ULN; 9. Expected survival=3 months; 10. Never used lapatinib before; 11. Willing to sign informed consent and comply with research requirements.
Exclusion criteria
Exclusion criteria: 1) Previously received chemotherapy and/or anti-her2 treatment for advanced breast cancer (allowing for 1 endocrine therapy); 2) The duration of the treatment of trastuzumab was less than 12 months; 3) LVEF decreased to <50% during the treatment of trastuzumab; 4) Brain metastasis; 5) Subjects are in pregnancy or lactation; 6) Other malignant tumors (except carcinoma in situ or basal cells); 7) Abnormal function of blood and liver and kidney; 8) There is a serious psychological or mental abnormality, and it is estimated that the subjects' adherence to this study is not strong; 9) Cardiac exclusion criteria: Uncontrolled high blood pressure or unstable angina; congestive heart failure(all NYHA grading); Serious arrhythmias that require medication; Myocardial infarction occurred within 6 months entering the group; 10) Other exclusion criteria: dyspnea at rest; Severe uncontrolled systemic disease (hypertension, cardiovascular, lung, metabolism, ulcer, fracture); 11) avoid if possible: Long-term or high-dose glucocorticoid therapy; immunosuppressive agent; Tumor necrosis factor (inhibitor); Anti t-cell antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, RR;clinical benefit rate, CBR;safety; | — |
Countries
China
Contacts
Public ContactDanmei Pang
First People's Hospital of Foshan
Outcome results
None listed