Breast cancer
Conditions
Interventions
Case series:apatinib+AI inhibitor
Sponsors
The first affiliated hospital of zhejiang university
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Metastatic HER2-negative, HR+ breast cancer with measurable lesions confirmed by histology or cytology; 2. Progression of disease after only one regimen of endocrine therapy or no endocrine therapy have been used for metastatic HER2-negative, HR+ breast cancer; 3. When the patient is enrolled, it must be more than 4 weeks before the end of radiotherapy, and the acute toxicity caused by previous radiotherapy must have been restored; local lesions receive radiotherapy cannot be used as measurable lesions; 4. Aged 18 to 75 years; 5. ECOG PS 0-2; 6. The expected lifetime of patients should be equal to or more than 3 month; 7. The main viscera function of patients must be normal, and should meet the following requirements: 1) blood routine examination meeting the standards:ANC=1.5×109/L; PLT=80×10^9/L; Hb=90g/L(no blood transfusion and blood components support within 14 days, not using G-CSF and other hematopoietic stimulating factor correction); 2) blood biochemical examination meeting the following standards: TBIL<1.5×ULNALTAST<2.5×ULN, hepatic metastasis ALT, AST < 5×ULNBUN and Cr=1×ULN, endogenous creatinine clearance =50 ml/min; 8. Women of childbearing age must have taken reliable contraceptive measures or have performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the result is negative, during the test and the last 8 weeks after experimental patients must be used appropriate methods of contraception, or surgery sterilization; 9. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: 1. Previously received an aromatase inhibitor (anastrozoleletrozoleexemestane), disease progression or recurrence at 12 months or 12 months after treatment with the aromatase inhibitor; 2. Have received any anti-angiogenic therapy; 3. Was allergic to the study drug (apatinib or AI) or any of its excipients; 4. Patients with symptomatic, disseminated to visceral, short-term risk of life-threatening complications (including uncontrolled large amounts of exudate [thoracic, pericardium, abdominal cavity], pulmonary lymphangitis, and more than 50% liver involvement); 5. Uncontrolled or symptomatic central nervous system transfer; 6. Major surgery, chemotherapy, radiation therapy, any research drug or other anticancer therapy were performed within 2 weeks prior to the study; 7. Previous or concurrent cases of other untreated malignancies, with the exception of cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 8. Patients with coagulation dysfunction (INR>1.5, APTT>1.5 UNL) or bleeding tendency; 9. Patients having undergone major surgery or having been selected for severe traumatic injuries, fractures or ulcers within two weeks of the start of the study; 10. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 11. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 3 month before randomization; 12. Urine protein=++, or urine protein in 24 hours=1.0g; 13. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA =500 IU/ml), hepatitis C, or combined hepatitis B and hepatitis C co-infection; 14. Myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac dysfunction, =2 persistent arrhythmia (according to NCI CTCAE version 4.03), any level of room Tremor, coronary/peripheral artery bypass, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism) was occurred within 6 months prior to the study; 15. Severe infections (intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks prior to the first dose, or unexplained fever >38.5 °C during screening/first administration; 16. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 17. The history of psychotropic substance or drug abuse; 18. Other serious physical or psychiatric illnesses or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator considers inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;QOL; | — |
Countries
China
Contacts
Public ContactXiaochen Zhang
The first affiliated hospital of zhejiang university
Outcome results
None listed