Breast cancer
Conditions
Interventions
Experimental group:Famitinib + SHR6390 + endocrine therapy
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Breast cancer patients diagnosed by pathological examination, with evidence of focal recurrence or metastasis, are not suitable for chemotherapy; 2. HR+, HER2- (2018 ASCO/CAP HER2 Detection Guidelines); 3. Phase Ib includes patients with advanced = 12 weeks; 7. According to RECIST 1.1 criteria, there is at least one measurable lesion; 8. ANC >= 1.5 x 10^9/L, PLT >= 90 x 10^9/L, Hb >= 90 g/L; TBIL = 50%, and QTc <= 470 ms.
Exclusion criteria
Exclusion criteria: 1. Previously received VEGFR TKI therapy; Phase II subjects previously received fulvestrant, everolimus or CDK4/6 inhibitor drug therapy; 2. Stage Ib excludes uncontrolled or clinically symptomatic central nervous system (CNS) metastasis; stage II excludes history of CNS metastasis; 3. Not suitable for endocrine therapy; 4. There are factors that obviously affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; 5. Participated in clinical trials of other drugs within 4 weeks before taking the study drug for the first time; 6. Suffering from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 7. Active HBV/HCV/HIV infection; 8. Suffering from heart disease; 9. Pregnant or breastfeeding women; those with childbearing potential who are unwilling or unable to take effective contraceptive measures; 10. The investigator judges that there are comorbidities that seriously affect patient safety and compliance; 11. Complicated severe infection within 4 weeks before the first dose, or unexplained fever > 38.5? during the screening period/before the first dose; 12. The researcher believes that there are any circumstances that make it inappropriate to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recommended phaseII dose;Objective response rate; | — |
Countries
China
Contacts
Public ContactMin Yan
Henan Cancer Hospital
Outcome results
None listed