Overview

A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer

Status:
Not yet recruiting
Trial end date:
2023-10-31
Target enrollment:
0
Participant gender:
Female
Summary
The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Criteria
Inclusion Criteria:

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.

Exclusion Criteria:

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.