breast cancer
Conditions
Interventions
None listed
Sponsors
Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Signed Informed Consent Form(ICF); (2) Women aged 18 to 75 years; (3) Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1; (4) Expected survival more than 12 weeks; (5) Histologically or cytologically confirmed invasive breast cancer, including locally advanced breast cancer (stage IIIb, stage IIIc) or recurrent and metastatic breast cancer; (6) HER2 negative confirmed by our laboratory tests (HER2 negative definition: IHC + or ISH-, if IHC2 + then ISH-); (7) At least one measurable lesion according to RECIST version 1.1 criteria; (8) At least failure of one chemotherapeutic regimen (combined or non-combined targeted therapy), and the progression needs to be confirmed by imaging; (9) Baseline LVEF >= 50% by ECHO; (10) Adequate organ function (bone-marrow, liver, renal and coagulation function) within 7 days prior to the first study treatment: 1) Leukocyte >= 3.0x10^9/L, neutrophil (ANC) >= 1.5x10^9/L, platelet count (PLT) >= 90x10^9/L, hemoglobin >=90 g/L; 2) Serum total bilirubin (TBIL) <= 1.5 ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0 ULN, and ALT and AST <= 5 ULN in patients with liver metastases; Urea nitrogen (BUN) and creatinine (Cr) <= 1.5 ULN; 3) The International Standardized Ratio (INR)<=1.5; Activated Partial Prothrombin Time (aPTT) or Partial Thrombin Time (PTT)<=1.5 ULN.
Exclusion criteria
Exclusion criteria: (1) Complicated with brain metastasis or nervous system oppression; (2) Uncontrollable hypertension (e.g. systolic blood pressure (>= 160 mmHg) or diastolic blood pressure (>= 100 mmHg) after taking antihypertensive drugs; (3) Severe hepatorenal insufficiency or recent history of myocardial infarction (within 3 months); (4) A third space effusion (e.g. pleural effusion and ascites) that cannot be controlled by drainage or other means. (5) Patients with serious uncontrolled medical diseases or acute infections (infection causes fever above 38 degrees); (6) Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption; (7) Known allergy to any components of the drug; (8) Known history of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history; (9) Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; (10) Pregnant or lactating, or those with fertility and positive baseline pregnancy test, or those of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; (11) The patient has a serious concomitant disease, or the researcher thinks that the patient is not suitable to participate in any other situation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;duration of response;disease control rate;overall survival;safety; | — |
Countries
China
Contacts
Public ContactXiaohua Zeng
Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment,Chongqing University Cancer Hospital,
Outcome results
None listed