ER+ / HER2- Advanced Breast Cancer
Conditions
Brief 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.
Interventions
DRUGSHR6390、Famitinib
SHR6390, oral;Famitinib, oral.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle | up to 28 days |
| (Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib | up to 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax | 6 months | — |
| Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2 | 6 months | — |
| Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC | 6 months | — |
| Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F | 6 months | — |
| AEs+SAEs | up to 24 months | from the first drug administration to within 30 days for the last treatment dose |
| Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac | 6 months | — |
| Objective Response Rate (ORR) | up to 24 months | Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI |
| Disease control rate (DCR) | up to 24 months | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1 |
| Duration of response (DoR) | up to 24 months | Time from documentation of tumor response to disease progression assessed among patients who had an objective response |
| Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F | 6 months | — |
| Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax | 6 months | — |
Countries
China
Outcome results
None listed