breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Women with a histopathological diagnosis of invasive breast cancer 2) Curative surgery was performed for an initial diagnosis of stage I to IIIA or stage IIIB breast cancer 3) HER2-negative breast cancer 4) Moderate or high risk of recurrence 5) If preoperative chemotherapy, preoperative endocrine therapy, or postoperative chemotherapy was given as previous treatment, The case that follows the regimen that was established in protocol 6) If postoperative endocrine therapy was being received, The case that follows the regimen that was established in protocol 7) If the conserved breast, thoracic wall, or regional lymph nodes underwent radiotherapy, at least 2 weeks have elapsed since the completion of treatment. 8) Within one year after surgery and within 6 months after the start of postoperative endocrine therapy 9) Age more than 20 years old , and signed informed consent of the patient for the registration. 10) ECOG performance status is 0 to 1 11) Oral intake is possible
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Bilateral (synchronous or asynchronous) breast cancer, inflammatory breast cancer 3) A history of previous treatment with oral 5-fluorouracil derivatives for 2 weeks or longer (Patients who received intravenous 5-fluorouracil can be enrolled.) 4) Serious diarrhea 5) Others, Serious complications 6) Pregnant women, nursing women, or women who want to become pregnant 7) Patients judged to be unsuitable for enrollment in the study by their physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint : disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint :overall survival, relapse-free survival, relative dose intensity, and safety | — |
Countries
Japan
Contacts
Breastopia Namba Hospital Breast Surgical oncology