Breast cancer
Conditions
Interventions
Endocrine therapy(Letrozole)
Sponsors
St. Luke's International Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Postmenopausal women with DCIS who meet the following inclusion criteria. (1) Patients with a definite diagnosis of DCIS by core needle biopsy. To exclude the possibility of invasive carcinoma, it will be confirmed by ultrasound that no lumps are formed. (2) Patients who has ER positive tumors (Allred total score (TS) &#61619;3) in immunohistochemical staining. Not concerned with PgR. (3) Patients who meet one of the following criteria for postmenopause. (i) Patients aged &#61619;55 years and moreover, at &#61619;1 year after the last menstruation. (ii) Patients aged <55 years with amenorrhea (spontaneous, drug-induced, or hysterectomy-induced menopause) in whom LH or FSH is &#61619;30 IU/mL or E2 is <20 pg/mL. (iii) Patients who underwent bilateral oophorectomy. (iv) Patients who have had amenorrhea for &#61619;3 months because of loss of ovarian function due to radiotherapy. (5) Patients without previous treatment for DCIS. (6) Patients with bone marrow, renal, and hepatic functions which are adequate to evaluate the safety of the study drug accurately. WBC: >3,500/mm3 Hemoglobin: >11.0 g/dL Platelet count: >10.0 x100000/mm3 Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution Total bilirubin: <1.5 times the upper limit of the normal range for the medical institution AST/ALT: <2.5 times the upper limit of the normal range for the medical institution. (7)Patients with performance status (ECOG Performance Status: PS) 0-1. (8)Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation. (9)Patients from whom written informed consent to participation in the study has been obtained.
Exclusion criteria
Exclusion criteria: (1)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.) (2)Patients with bilateral DCIS. (3)Patients within 30 days after completion of treatment with the investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical usefulness Safety | — |
Countries
Japan
Contacts
Public ContactTakashi Kuwayama
St. Luke's International Hospital Breast Surgical Oncology
Outcome results
None listed