breast cancer
Conditions
Interventions
Experimental group:anlotinib combined with fulvestrant
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, female, ECOG score 0-1, is expected to survive more than 3 months; 2. Premenopausal women need to take effective ovarian function suppression methods, such as drug suppression and ovariectomy; 3. According to the RECIST 1.1 standard, there are objectively measurable breast cancer lesions; 4. HR-positive and HER2-negative breast cancer diagnosed by histology; 5. No more than one systemic chemotherapy for metastatic disease; 6. Disease progression after receiving aromatase inhibitor (AI) treatment: (1) For patients receiving AI adjuvant treatment, the AI treatment time is required to be >=2 years, and the treatment end time is less than 1 year from the recurrence time; (2) For patients receiving first-line AI treatment, the AI treatment time is required to be >=6 months. 7. The main organs are functioning well, and the inspection indicators within 7 days before enrollment meet the following requirements: (1) Routine blood examination (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): 1) Hemoglobin (HB) >=90 g/L; 2) Neutrophil count (ANC) >= 1.5x10^9/L; 3) Platelet count (PLT) >=80x10^9/L. (2) Biochemical inspection: 1) Total bilirubin=60mL/min (Cockcroft-Gault formula); 8. Volunteer to participate in this study, sign an informed consent form, and have good compliance.
Exclusion criteria
Exclusion criteria: 1. During pregnancy or lactation; 2. Those who are known to be allergic to any of the drugs in the study; 3. Those with visceral crisis; 4. Accompanied by uncontrolled or high-load CNS transfer; 5. Have received fulvestrant treatment in the past, or have received similar anti-angiogenic drug treatment; 6. Suffered from other malignant tumors within 3 years before enrollment, except for fully treated basal cell carcinoma or squamous cell skin cancer or cervical carcinoma in situ; 7. Unreduced toxicity that is higher than (CTCAE 5.0) level 1 or above due to any previous treatment, but does not include hair loss; 8. Those who have multiple factors that affect oral medications (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 9. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg 150 mmHg, diastolic blood pressure> 90 mmHg); (2) Those with a history of unstable angina; those who were newly diagnosed with angina within 3 months before screening or had myocardial infarction within 6 months before screening; arrhythmias (including QTcF: males >=450 ms) require long-term antiarrhythmic Drugs and New York Heart Association grade >= Grade ii cardiac insufficiency; (3) Active or uncontrolled serious infection (>=CTCAE 4.0 Grade 2 infection); (4) People with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (5) Diabetes is poorly controlled (fasting blood glucose (FBG)> 10mmol/L); (6) Urine routines suggest that urine protein is >=++, and the 24-hour urine protein quantification is confirmed to be greater than 1.0g; (7) Patients who have epileptic seizures and need treatment. 14. Regardless of the severity, patients with any bleeding constitution or medical history; patients with any bleeding or bleeding event >= Grade 3 (CTCAE 5.0) within 4 weeks before enrollment, and unhealed wounds, ulcers or fractures; 15. Those who have had arterial/venous thrombotic events before enrollment or within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 16. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 17. Participants in clinical trials of other ant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Clinical Benefit Rate;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactWang Xiaojia
Zhejiang Cancer Hospital
Outcome results
None listed