Breast Cancer
Conditions
Interventions
All of the subjects:Letrozol
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Femal patients aged 18 years and 70 years; 2. Histologically confirmed diagnosis of ER/PR(+) breast Infiltrating ductal carcinoma in Stage I-III; 3. Must have progressed on surgery and Adjuvant therapy,i.e. chemotherapy and/or radiotherapy; 4. Eastern Cooperative Oncology Group(ECOG) score of 0 or 1; 5. Life expectancy of at least twelve(12)months; 6. Must be eligible for treatment with Aromatase Inhibitors; 7. Written inform consent that is consistent with guidelines.
Exclusion criteria
Exclusion criteria: 1. Stage IV metastatic disease; 2. Patients unable to comply with the protocol; 3. Long term treatment with CYP19A1 Inhibitors; 4. Patients unwilling or unsuitable for stopping treatment with effects of sex hormone levels; 5. Severe bone marrow suppression and liver and kidney dysfunction,such as: (1) Absolute neutrophil count(ANC) 1.5 times upper limit of normal; (5) Aspartate amino transferase (AST) or alanine amino transferase (ALT) )>2 times or Alkaline phosphatase(ALP)>2.5 times the upper limit of normal (ULN)(if related to liver matastases >5 times ULN); (6) serum creatinine > 1.5 times upper limit of normal; 6. Known hypersensitivity to Aromatase Inhibitors; 7. Known pre-existing Osteoporosis; 8. Any other current malignancy; 9. Use of any investigational drug within 30 days of beginning; 10. Known or suspected alcohol abuse(>20g/d).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CYP19A1;E2;activity of aromatas; | — |
Countries
China
Contacts
Public ContactLUO Ting
Outcome results
None listed