Breast cancer
Conditions
Interventions
Neoadjuvant endocrine therapy (goserelin + tamoxifen)
Sponsors
St. Luke's International Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Premenopausal women with invasive breast cancer who meet the following inclusion criteria. (1) Clinical Stage I-IIB: T1-3N0M0 (2) Patients with a definite diagnosis of invasive breast cancer by core needle biopsy. (3) Patients who meet one of the following criteria for premenopause. (i) Periodic menstruation bleeding. (ii) Patients with amenorrhea in whom LH or FSH is <30 IU/mL and E2 is >10 pg/mL. (4) Patients who has ER positive tumors (Allred total score (TS) is 3 or moreover) in immunohistochemical staining. Not concerned with PgR. (5) HER2 negative by IHC or FISH (6) Patients with bone marrow, renal, and hepatic functions which are adequate to evaluate the safety of the study drug accurately. WBC: >3,000/mm3 Hemoglobin: >9.0 g/dL Platelet count: >10.0 x10000/mm3 AST/ALT: <1.5times the upper limit of the normal range for the medical institution. Serum creatinine: <1.25 times the upper limit of the normal range for the medical institution. (7) ECOG PS is 0-2. (8) Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples
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) 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. (4) Patients with active double cancer. (5) Inflammatory breast cancer (6) Synchronous or asynchrous bilateral breast cancer. (7) Allergy for radio-enhancer (8) New test drug (9) Severe psychosomatic disease (10) 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, M.D.
St. Luke's International Hospital Department of Breast Surgical Onocology
Outcome results
None listed