Breast Cancer
Conditions
Interventions
Case series:Fulvestrant+Apatinib
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosis of adult female advanced breast cancer (aged 18 - 70 years old), not suitable to accept surgery or radiotherapy for healing; 2. Histologically diagnosis of hormone receptor positive (ER and/or PR+), HER2 negative breast cancer(ER positive: immunohistochemistry (IHC) >1% tumor cell staining; PR positive: immunohistochemistry (IHC) >1% tumor cell staining; HER-2 negative: immunohistochemistry 0, 1+, or 2+ while FISH/CISH negative); 3. Patients received no or =1 line of prior endocrine therapy for advanced disease; 4. Eligible patients were either postmenopausal or received ovarian suppression; 5. ECOG 0-2, Life expectancy = 3 months; 6. Imaging examination within 2 weeks before enrollment are needed (can be check at the local Grade IIIA hospitals), to assess the tumor lesions before treatment; 7. Treatment-related toxicity at randomization should be relieved to NCI CTCAE (version 4.03) = grade 1 (except alopecia or other toxicities of no risk to patient safety based on the researchers' judgment); 8. Blood tests were basically normal within 1 week before enrollment; 9. Normal liver and kidney function within 1 week before enrollment; 10. Signed informed consent prior to any study-specific procedures.
Exclusion criteria
Exclusion criteria: Any of the following items cannot be grouped: 1. Known brain or leptomeningeal metastasis; 2. Prior anti-VEGF or VEGFR tyrosine kinase therapy; 3. Major (within 28 days) or minor (within 7 days) surgical procedure; 4. Ongoing uncontrolled hypertension blood pressure:systolic=140 mmHg and/or diastolic=90mmHg); 5. New York Heart Association grade= 2 congestive heart failure; 6. History of hypertensive crisis or encephalopathy; 7. Uncontrolled seizures despite standard medication; 8. History (within the past 6 months) of myocardial infarction, unstable angina, stroke, abdominal fistula or abscess, or signifcant bleeding episode; 9. History of GI perforation within 12 months; 10. Pregnant or lactating women; 11. A person who has been confirmed to be allergic to apatinib and/or its excipients; 12. Received chemotherapy or target therapy for advanced breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CBR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR;QoL; | — |
Countries
China
Contacts
Public ContactHerui Yao
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed