Estrogen receptor positive, pre-menopausal breast cancer
Conditions
Interventions
Group A: tamoxifen Administration of 20mg tamoxifen daily for 8 weeks (day1-56)
Group B: goserelin acetate Subcutaneous injection of goserelin acetate each 4 weeks for 8 weeks (day 1,28)
Group
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Invasive breast cancer in pathological examination 2) 30 to 55 years old women who was comformed menstruation in recent 3 months 3) T1-2,N0,M0 in TNM classification 4) No previous chemotherapy, radiation, endocrine therapy, immunotherapy 5) Existance of measurable lesion 6)ER and/or PgR positive(IHC >10%) 7)HER2 negative 8)Performance Status 0-1 9)Sustained major organ funcrion WBC >= 3,000/mm3,<=12,000/mm3 Netrophil >= 2,000/mm3 PLT >= 10x10 4/mm3 Hb >= 8.0 g/dl AST(GOT),ALT(GPT)<=facility standard value x 1.5 T.Bili <=facility standard value x 1.25 Cre <= facility standard value x 1.5 Normal in electrocardiogram 10)Written informe consent
Exclusion criteria
Exclusion criteria: 1) hypersensitivity to test drug 2) serious complication (malignant hypertention, congestive heart failure, coronary failure, cardiac infarction in last 6 month, arhythmia which need treatment, infection disease, bleeding tendency, etc.) 3) Patients who administrate anticlotting drug or SSRI 4)Patinent who have double cancer 5)Ductal carcinoma in situ or inflamatory breast cancer 6) Bilateral breast cancer, male breast cancer 7) Pregnant women, breat-feeding mother, possibility of pregnancy 8) History of thrombosis 9) History of mental disease or under medical treatment. 10)Patient regarded as inadequate by responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Suppression of Ki-67 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Response rate Histopathological response Predictive factor Relapse-free survival | — |
Countries
Japan
Contacts
Public ContactDaisuke Shimizu
Yokohama City Minato Red Cross Hospital Breast Surgery
Outcome results
None listed