Breast Cnacer
Conditions
Interventions
fruquintinib + eribulin :fruquintinib,
fruquintinib + eribulin :Eribulin
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntarily join the research and sign an informed consent form; 2) Age = 18 years old; 3) Histologically confirmed as HR+, HER2 negative advanced breast cancer and not suitable for radical resection; 4) Has received at least two chemotherapy drugs (adjuvant/metastatic stage) in the past, and the previous chemotherapy regimen must include one paclitaxel and one anthracycline drug, and has received at least first-line CDK4/6 inhibitors combined with endocrine therapy progression (adjuvant/metastatic stage); 5) ECOG PS = 2; 6) The toxicity of previous anti-tumor treatments has returned to = 1 level (excluding hair loss, pigmentation, or other toxicity that the researchers believe is not a safety risk to patients); 7) Female patients with negative urine or blood HCG (excluding menopause and hysterectomy), female patients of childbearing age and their partners take effective contraceptive measures during the trial period and within 6 months after the end of the last medication (such as combining hormones (including estrogen and progesterone) to inhibit ovulation, combining progesterone contraception to inhibit ovulation, intrauterine devices, intrauterine hormone release system, bilateral salpingectomy, and vasectomy) Avoid sexual activity, etc.
Exclusion criteria
Exclusion criteria: 1) Known allergies to fruquintinib or eribulin or components; 2) Second tumor within the past 5 years, except cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site; 3) Uncontrolled serious medical illness that, in the opinion of the investigator, will affect the patient's ability to receive treatment under the study protocol, such as concomitant serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled infection, etc.; 4) The patient currently has active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator; or those who have had gastrointestinal perforation or gastrointestinal fistula in the past, which have not healed after surgical treatment; 5) Patients with evidence or history of bleeding tendency within 2 months before the first dose (such as melena, hematemesis, hemoptysis, bloody stool, etc.); 6) During screening, it is found that the tumor has invaded large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, etc., and there is a greater risk of bleeding as judged by the investigator; 7) History of arterial thrombosis or deep vein thrombosis within 6 months before the first dose; or a stroke and/or transient ischemic attack within 12 months; Patients with thrombosis due to implantable intravenous infusion pump or catheter-derived thrombosis, or superficial venous thrombosis, except for those with stable thrombosis after conventional anticoagulation therapy; 8) Pregnant or lactating female patients; 9) Have any other disease, metabolic disorder, and have reason to suspect that it may lead to a contraindication to the use of the trial drug, or affect the reliability of the study results; 10) Major surgery within 28 days prior to the first dose; 11) Other patients who are judged by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;AE; | — |
Countries
China
Contacts
Public ContactZhang Lili
Jiangsu cancer hospital
Outcome results
None listed