HER2 negative breast cancer
Conditions
Interventions
Sponsors
Cancer Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) aged 18-70 year old female patients; 2) at least one target can be defined according to the evaluation criteria of solid tumor efficacy (RECIST 1.1), and there is no radiation therapy (or other local treatment) in the target area unless radiotherapy or other local treatment is completed; 3) the recurrence and metastatic HER -2 negative breast cancer was confirmed by pathology; the HER-2 negative criterion was HER-2 (- / + +). If HER-2 (+ +), FISH/CISH test confirmed that HER-2 amplification was negative; 4) at least 1 systemic chemotherapy schemes have been accepted, and at most 3 HER-2 negative metastatic breast cancer patients who have received 3 systemic chemotherapy schemes (systemic chemotherapy does not include neoadjuvant chemotherapy and adjuvant chemotherapy); 5) previous plans must have used at least one taxane containing chemotherapeutic agent and the disease progression or taxane chemotherapy drugs used for more than 6 cycles; 6) ECOG PS 0 - 1; 7) the expected life period is more than March; 8) the main organs are functioning normally, that is, they meet the following criteria: The standard of blood routine examination should conform to (no transfusion and blood products within 14 days), without G-CSF and others. Correction of hematopoiesis factor: Hb > 90g/L; ANC > 1.5 *10^9/L; PLT > 100*10^9/L; Biochemical examination should conform to the following standards: TBIL-<1.5 *ULN; ALT, AST < 2.5 *ULN, <5 *ULN with liver metastases. BUN and Cr less than 1 *ULN or endogenous creatinine clearance rate was more than 50mL/min (Cockcroft Gault); 9) women of childbearing age must carry out pregnancy induced pregnancy test (serum) within the first 7 days of the group and have negative results, and are willing to adopt an appropriate method of contraception within 8 weeks after the trial and the last trial; 10) participants voluntarily joined the study, signed informed consent, and had good compliance and follow-up.
Exclusion criteria
Exclusion criteria: Those with hypertension and who were unable to fall into the normal range after treatment with hypotensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 1) had severe cardiovascular disease in the past: myocardial ischemia or myocardial infarction over grade II, and poor control. Arrhythmia (including QTc interphase women more than 470 MS); III ~IV level cardiac insufficiency according to NYHA standard, or cardiac color Doppler examination of left ventricular ejection fraction (LVEF) 1.0g); 3) abnormal coagulation function (INR>1.5, APTT>1.5ULN), with bleeding tendency; 4) patients with mental substance abuse history who are unable to quit or have mental disorders; 5) patients who had previously used other small molecule TKI targeted drugs; 6) according to the researchers' judgement, there are other serious hazards that affect patients' safety or affect patients' completion of research; 7) patients with active brain metastases or leptomeningeal diseases; 8) pregnant or lactating women; 9) researchers think it is not suitable for the participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;DCR;ORR; | — |
Countries
China
Contacts
Public ContactJing Chen
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed