early breast cancer
Conditions
Interventions
Sponsors
a Grant-in-Aid for research of cancer treatment from the Ministry of Health, Labor and Welfare of Japan (No.21-7-4)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. tumor size is 3 cm or smaller on palpation 2. pathologically axillary node negative (or no metastasis in sentinel node(s) if only sentinel node biopsy was done) and no distant metastasis or a case of ductal carcinoma in situ 3. No preoperative treatments including chemotherapy, endocrine therapy and radiotherapy 4. 50 years old or older at definitive surgery and postmenopausal 5. a tumor was resected with wide local excision and the pathological margins were negative (tumor cells must be absent in the zone of 5mm or more from the margins) 6. no pathological findings of lymph vessel invasion 7. estrogen receptor positive in the primary tumor 8. within 8 weeks after the definitive surgery 9. a written informed consent was obtained
Exclusion criteria
Exclusion criteria: 1. multicentricity of the tumor is suspected 2. past history of breast cancer or synchronous bilateral breast cancer 3. trastuzumab treatment is planned 4. the patient has mental disorder 5. any reason the physician believes that the patient is not appropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-breast recurrence rate | — |
Countries
Japan
Contacts
Public ContactShozo Ohsumi
National Hospital Organization Shikoku Cancer Center Breast Oncology
Outcome results
None listed