Breast cancer
Conditions
Interventions
Endocrine therapy (letrozole)
Sponsors
St. Luke's International Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Postmenopausal women with invasive breast cancer who meet the following inclusion criteria. (1) Patients with a definite diagnosis of invasive breast cancer by core needle biopsy. (2) Clinical Stage I-IIIA: T1-3N0-1M0 (excluded N2) (3) Patients who has ER positive tumors (Allred total score (TS) is 3 or moreover) in immunohistochemical staining. Not concerned with PgR. (4) HER2 negative by IHC or FISH (5) Patients who meet one of the following criteria for postmenopause. (i) Patients aged 60 years and moreover.(ii) Patients aged less than 60 years old with amenorrhea (spontaneous, drug-induced, or hysterectomy-induced menopause) in whom LH or FSH is more than 30 IU/mL or E2 is <20 pg/mL. (iii) Patients who underwent bilateral oophorectomy. (6) Subjects must meet all of the following criteria for inclusion in the study. i) Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution. ii) AST/ALT: <2.5 times the upper limit of the normal range for the medical institution. (7) ECOG PS is 0-1. (8) Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation. (9) Patients from written informed consent to participation in the study has been obtained.
Exclusion criteria
Exclusion criteria: (1) Patients with previous treatment for the breast cancer. (2) Patients receiving drugs having a potential influence on the status of sex hormones (hormone replacement therapy, raloxifene, etc.). (However, patients after washout for at least 2 months can be enrolled.) (3) Synchronous or asynchrous bilateral breast cancer. (4) Patients with active double cancer. (5) Patients with myocardial infarction or congestive heart failure at the past history, or patients who need treatment of ischemic hear disease, arryhythmia or valvular disorder. (6) Patients within 30 days after completion of treatment with the investigational drugs. (7) Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological response Safety Clinical usefulness Changing of Ki67-score Disease Free Survival | — |
Countries
Japan
Contacts
Public ContactKoichiro Tsugawa
St. Luke's International Hospital Department of Breast Surgical Oncology
Outcome results
None listed