Breast cancer
Conditions
Interventions
Single arm:Anlotinib plus Irinotecan
Sponsors
The Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female between 18-75 years old; 2. ECOG PS 0-1 and Life expectancy of at least 3 months; 3. Pathologically confirmed Advanced HER-2 negative breast cancer;Judgment criteria: HER-2 (- /±/ +) is confirmed by immunohistochemistry,If HER-2 (+ +), FISH/CISH test is needed to confirm that HER-2 amplification is negative; 4. At least one measurable lesion (by RECIST1.1) and the target has not received radiotherapy (or other local therapy); 5. Breast cancer patients who have failed from at least one systemic chemotherapy. 6. The patients have enough organ function. The laboratory test indexes must comply with the following requirements: (1) Blood routine(without blood transfusion or hematopoietic stimulating factor within 7 days before screening ): Hemoglobin (HB)>=9.0g/L; Absolute value of neutrophil (ANC)>=1.5 * 10^9/L; Platelet (PLT)>=80 * 10^9/L; (2) Liver and Renal function(without blood or albumin transfusion within 7 days before screening ): ALT and AST=60 ml/min; (3) Blood coagulation function: Activated partial thromboplastin time, international standardized ratio adn prothrombin time =50%; 7. Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative and must be non-lactation subjects; Women are willing to adopt the appropriate methods of contraception during the trial and 6 months after last administration; 8. Subjects volunteered to join the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. The patients who received anti-angiogenic drugs including anlotinib, apatinib or bevacizumab; 2. Combined disease/ history: 1) Clinical significant hemoptysis occurred within 3 months before admission (daily hemoptysis was greater than 50ml), or significant clinical bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood or above, or suffering from vasculitis, etc; 2) Arteriovenous thrombosis events occurred within 6 months before grouping, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by venous catheterization due to early chemotherapy) and pulmonary embolism; 3) Hypertension, which can not be well controlled by antihypertensive drugs (systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg); Myocardial infarction, severe / unstable angina pectoris, cardiac insufficiency above NYHA 2, supraventricular or ventricular arrhythmias with clinical significance, and symptomatic congestive heart failure occurred within 6 months before grouping; 4) Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g. diabetes, pulmonary fibrosis and acute pneumonia); 5) Renal insufficiency: urine routine indicates urinary protein >=+ +, or confirms 24-hour urinary protein >=1.0g; 6) History of live attenuated vaccine vaccination within 28 days before the first study medication or expected live attenuated vaccination during the study period; 7) Human immunodeficiency virus infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA >=500 IU/ml; hepatitis C, defined as HCV-RNA higher than the lower limit of detection by analytical method) or co-infection of hepatitis B and hepatitis C; 8) There were severe infections within 4 weeks before the first administration, including, but not limited to, bacteremia and severe pneumonia requiring hospitalization; active infections requiring systemic antibiotics treatment of grade CTCAE >=2 within 2 weeks before the first administration, or unexplained fever >38.5 degree C during the screening period / before the first administration (the researchers judged that fever caused by tumors could be included in the group); there was evidence of active tuberculosis infection within 1 year before administration; 9) Any other malignant tumor has been diagnosed within 3 years before enrollment, except for fully treated basal cell carcinoma or squamous cell skin cancer or cervical carcinoma in situ; 10) Major surgery was performed within 28 days before enrollment (tissue biopsy required for diagnosis and central venous catheterization via peripheral venipuncture are allowed); 11) Subjects who have previously received or are prepared to receive allogeneic bone marrow transplantation or solid organ transplantation; 12) Patients with peripheral neuropathy =2 grade 2; patients with active brain metastasis, carcinomatous meningitis, spinal cord compression, or diseases found in brain or leptomeninges by imaging CT or MRI examination during screening (patients with brain metastasis who had completed treatment 14 days before admission and whose symptoms were stable can be enrolled in the group, but no symptoms of cerebral hemorrhage should be confirmed by cranial MRI, CT or venography); 13) Factors that significantly affect the absorption of oral drugs, such a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Object Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;Progression-free survival;Safety; | — |
Countries
China
Contacts
Public ContactXiaohong Wu
The Affiliated Hospital of Jiangnan University
Outcome results
None listed