Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jiangsu HengRui Medicine Co., Ltd.
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Female subjects aged 18 to 75 years old；
2. ECOG performance status 0-1;
3. Life expectancy is not less than 12 weeks;
4. Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer;
5. Participants with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1;
6. Adequate function of major organs;
7. Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.
You may not be if
1. Confirmed diagnosis of HER2 positive disease;
2. Participants who previously received SHR6390 or VEGFR inhibitors;
3. Allergy to study drug or its components;
4. Participated in other drug clinical trials within 4 weeks before the first dose;
5. Other malignancies within 3 years, except cured non-melanoma skin cancer , skin basal cell carcinoma and squamous-cell carcinoma or carcinoma in situ of the cervix;
6. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention；
7. Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment;
8. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein \>1.0g;
9. Active HBV/HCV/HIV infection;
10. The investigators determined that other conditions were inappropriate for participation in this clinical trial；
11. Pregnant or breast-feeding women;
12. Central nervous system (CNS) invasion.
Clareo Health | A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
