Breast Cancer
Conditions
Interventions
Group 1:everolimus plus letrozole
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adult women (older than 18 years old), locally advanced or metastatic breast cancer that can not be cured by surgery or radiotherapy; 2. ER/PR positive, with histologically or cellular conformed; 3. Post-menopausal women; 4. Exemestane resistance; 5. Before entering the group, the patients must be confirmed by radiological examination of disease progression; 6. According to RECIST criteria, there must be at least one dimensional size of disease that can be can be measured by CT or MRI technology; 7. Bone marrow function properly: ANC more than 1.5*10^9/L; PLT more than 100*10^9/L; HGB more than 90g/L; INR less than at least 2; 8. Liver function properly: TBIL less than at least 1.5*ULN; INR less than 1.3*ULN (In patients receiving anticoagulant therapy INR less than 3; ALT and AST less than 2.5*ULN(For patients with liver metastasis: AST and ALT less than at least 5*ULN); 9. Proper kidney function: Cr less than at least 1.5*ULN; 10. Fasting serum cholesterol: less than at least 300 mg/dL or less than at least 7.75 mmol/L, and FBTG less than at least 2.5*ULN. Note: When these thresholds are exceeded one or two, the patients can only take the appropriate lipid - lowering drugs at the beginning, then be selected for the test; 11. ECOG scores less than 2; 12. Sighned informed consent, willing and able to comply with the requirements of the research program.
Exclusion criteria
Exclusion criteria: 1. HER2 overexpression (IHC 3+ or FISH positive); 2. No measurable target lesion; 3. Have accepted more than first - line chemotherapy after metastasis and recurrence; 4. Previously received mTOR inhibitor treatment (sirolimus, temsirolimus, everolimus); 5. Allergic to mTOR inhibitors; 6. Within 5 years before entering the group, there are other malignant tumor history, except cervical or uterine carcinoma in situ, basal or squamous cell carcinoma and non melanoma skin cancer that have accepted treatment; 7. Have received radiotherapy within 4 weeks before entering the group, radiotherapy on local bone metastasis that can cause pathological fracture, except which have completed 2 weeks befor entering the group; 8. Undergoing hormone replacement therapy; 9. Brain metastasis or other central nervous system (CNS) transfer; 10. Patients that are receiving long-term corticosteroids or other immunosuppressive therapy, except inhaled corticosteroids; 11. Bilateral diffuse carcinomatous lymphangitis; 12. Patients known with a history of HIV seropositive; 13. Active bleeding diathesis, or taking anti-vitamin K drugs; 14. Patients suffering from any severe and/or uncontrollable disease disease, such as: (1) Unstable angina period, symptomatic congestive heart failure, myocardial infarction less than 6 months prior to randomization, uncontrollable severe cardiac arrhythmia; (2) Attack or severe infection can not be controlled; (3) Liver cirrhosis, chronic active phase of hepatitis or chronic persistent hepatitis; (4) Gastrointestinal diseases that can significantly change the the absorption of the drug, (eg.ulcerative disease, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome); (5) Active skin, eyes, mucous membrane or gastrointestinal diseases above I degrees; (6) Severe 'pulmonary' insufficiency (Lung spirometry and DLCO is 50% normal or less, static indoor air oxygen saturation is 88% or below); 15. Patients have received the treatment of strong inhibitors or inducers of CYP3A isoenzyme within the last 5 days before?entering the group; 16. History of non-compliance with medical programmes; 17. Patients unwilling or unable to comply with the agreement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Reaction time;Safety; | — |
Countries
China
Contacts
Public ContactHuiping Li
Outcome results
None listed