Breast cancer
Conditions
Interventions
Neoadjuvant endocrine therapy (Letrozole)
Sponsors
Tohoku University Hospital, KKR Tohoku Kosai Hospital, Miyagi Cancer Center, Ishinomaki Red Cross Hospital, and Nihonkai General Hospital
Tohoku University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with noninvasive (including the suspicion) breast carcinoma, which was detected by US etc and diagnosed by biopsy etc, who hope the treatment by breast conserving surgery. 2. The breast carcinoma was positive for estrogen receptor (ER) by immunohistochemistry (more than Allred score 4 or more than 10% of ER-positive cells). 3. Postmenopausal women with breast carcinoma who apply to one or more following criteria. 1) Patients aged more than 60 years. 2) Patients aged less than 60 years old with amenorrhea (more than one year). 3) Patients who underwent bilateral oophorectomy. *If menopausal status is unclear in patients aged less than 60 years, it is determined by serum FSH and E2 levels. 4. Patients without previous treatment for the breast cancer. 5. ECOG PS is 0-1. 6. Subjects must meet all of the following criteria for inclusion in the study. 1) AST/ALT: <2 times the upper limit of the normal range for the medical institution. 2) Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution. 7. Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation. 8. Patients from whom written informed consent to participation in the study has been obtained.
Exclusion criteria
Exclusion criteria: 1. Synchronous or asynchrous bilateral 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 8 weeks can be enrolled.) 3. Patients who are being treated of cerebral infarction at the time of the enrollment. 4. 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. 5. Patients within 30 days after completion of treatment with the investigational drugs. 6. Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sex hormone levels and responsive genes at approximately 12-16 weeks after treatment of letrozole | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Pathological response, Safety | — |
Countries
Japan
Contacts
Public ContactTakanori Ishida
Tohoku University Graduate School of Medicine Department of Surgical Oncology
Outcome results
None listed