- 1. Female patient with primary, infiltrative breast cancer who has been diagnosed on a
histological basis. 2. Stage I-IIIB at the first diagnosis and underwent curative
resection. 3. The patient was non-pCR after preoperative chemotherapy including
anthracycline agents and paclitaxel or docetaxel; that is, she had undergone primary
tumor resection and pathologically confirmed to have residual cancer cells.The
previously adminstered preoperative chemotherapy must have involved 8 cycles of EC-T
or 6 cycles of TEC.If HER-2 is positive, trastuzumab is applied with T chemotherapy 4.
The patient has high risk: young;triple negtive breast caner; positive axillary
lymphnode;HER-2 positive;ect 5. The patient's general performance status is 0 to 1. 6.
The patient must have no carry-over of efficacy from any previous treatment. 7. The
patient has maintained sufficient organ function to permit valid evaluation. 8. The
patient must have no adverse drug reactions of grade 2 or higher carried over from
previous treatment. 9. The patient's creatinine clearance is higher than 50 ml/min 10.
The patient has personally given written, informed consent to participate in this
- 1. The patient is considered to require postoperative chemotherapy other than
capecitabine and vinorelbine. 2. The patient has previously been treated with oral
5-FU agents (however, previous treatment with iv 5-FU is acceptable). 3. The patient
has either simultaneous or non-simultaneous bilateral breast cancer. 4. The patient
has a history of other malignancies or synchronic multiple cancers. However, lesions
corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy
are eligible. 5. The patient is pregnant, has the potential and/or wishes to become
pregnant, or is breastfeeding. 6. The patient has previously had an organ transplant.
7. The patient shows hypersensitivity to fluoropyrimidine agents; has previously
suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history
of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or
exemestane. 8. The patient is currently suffering from serious complications or
associated disorders, such as malignant hypertension, congestive heart failure,
coronary failure, arrhythmias requiring treatment, infectious diseases, and/or
hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous
6 months. 9. The patient has a fever, and there is the possibility that she has an
infection. 10. The patient has been shown to have metastasis to other organs. 11. The
patient requires treatment for epilepsy and/or central nervous system disorders. 12.
The patient is currently being treated for, or has a history of, psychiatric disease.
13. It would be difficult to orally administer drugs to the patient, and/or she
suffers from functional insufficiency of the upper gastrointestinal tract and/or
malabsorption syndrome. 14. For any other reason, the investigator or sub-investigator
has judged the patient to be ineligible for participation.