Breast Cancer
Conditions
Interventions
None listed
Sponsors
Ministry of Health, Labour and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all the following criteria are eligible: 1)Patients who are histopathologically diagnosed with invasive breast cancer by biopsy, etc.; 2)Estrogen receptor-positive (the percentage of positive cells is 10% or more by immunohistological methods); 3)Stage I to IIIA; 4)Her2 negative (2+ and FISH-negative or 1+ or less); 5)Age when the treatment is initiated: 21 years or older; 6)Negative pregnancy test for patients who are in the reproductive age group; 7)Tissue specimens for measurement of Ki67 are available before initiating treatment; 8)Patients who are fully informed of and understand preoperative tamoxifen therapy properly before participation in this study, and subsequently submit their voluntary written informed consent to receive the therapy.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are excluded from this clinical study: 1)Non-invasive cancer; 2)Renal dysfunction (dialysis patients with serum creatinine 2.5 mg/dL); 3)Patients with severe hepatic dysfunction (AST, ALT, and total bilirubin levels are all 1.5 or more times the institutional reference range); 4)Patients who are considered to have difficulty in complying with the procedures, observations, etc. specified in the protocol; 5)Patients who are considered to be inappropriate as a subject of this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Ki-67 labeling index after tamoxifen treatment | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactHitoshi Zembutsu
National Cancer Center Research Institute Division of Genetics
Outcome results
None listed