HER2-Negative Advanced Breast Cancer
Conditions
Interventions
HR-positive cohort:Anlotinib combined with albumin-bound paclitaxel
TNBC cohort:Anlotinib combined with chemotherapy (capecitabine /eribulin / vinorelbine).
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. HER-2 negative breast cancer confirmed by histomathology: the criteria for HER-2 negative diagnosis are determined by immunohistochemistry as HER-2 (-/±/+). If HER-2 (++) is detected, FISH/CISH test is required to confirm that HER-2 is not amplified; 2. Female patients aged 18-75 years; 3. ECOG score 0-1; Estimated survival >=3 months; 4. HR+/HER2- advanced breast cancer patients with recurrence must have received prior CDK4/6 inhibitor therapy, with =1 line of chemotherapy allowed. For TNBC (triple-negative breast cancer) patients, 1-2 lines of chemotherapy in the recurrent stage are permitted. 5. The main organs function well, and the laboratory test indexes meet the following requirements: blood routine examination:ANC >=1.5 x 10^9/L; PLT>=90×10^9/L Blood biochemistry: TBIL<=1.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3×ULN (or =5×ULN for patients with liver metastases); 6. 12-lead electrocardiogram (ECG): QTc interval corrected by Fridericia’s method (QTcF) <480 ms for females; 7. Women of reproductive age must agree to use a highly effective method of contraception during the study period and for 6 months after the last administration of the study drug; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; 8. Subjects voluntarily participated in this study, signed informed consent, had good compliance and were willing to cooperate with follow-up; 9. Patients with only bone metastases or malignant pleural/ascites effusions (non-measurable lesions) are also eligible for enrollment.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with bevacizumab, anlotinib and other antiangiogenic agents; 2. Patients with symptomatic brain/leptomeningeal metastases and/or spinal cord metastases; 3. There are significant factors affecting the absorption of oral drugs; 4. Receiving any anti-tumor therapy for any other tumor at the same time; 5. Other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 6. Had any history of cardiac disorders including: (1) medically treatable or clinically significant arrhythmias; (2) myocardial infarction; (3) heart failure; (4) any other cardiac diseases judged by the investigators to be unsuitable for the trial; 7. Patients with known allergic history to the components of this regimen; A history of immunodeficiency, including testing positive for HIV, active hepatitis B/C or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8. A definite previous history of a neurological or psychiatric disorder, including epilepsy or dementia; 9. Pregnant, lactating women, fertile women with a positive baseline pregnancy test, or women of childbearing age who were unwilling to use effective contraception throughout the trial; 10. Concomitant diseases (including but not limited to severe hypertension, severe diabetes, etc.) that seriously endanger the safety of patients or affect the completion of the study according to the judgment of the investigators; 11. The researchers believe that patients are not suitable for in any other situation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;safety;Biomarker exploration; | — |
Countries
China
Contacts
Public ContactYuan yuan
Jiangsu Cancer Hospital
Outcome results
None listed