Open labelled multicenter randomized comparative trial of high-dose toremifene for non-steroidal aromatase inhibitor resistant breast cancer compared to exemestane

INTERVENTION: TOR: Toremifene (120mg) is orally administered once a day everyday. EXE: Exemestane (25mg) is orally administered once a day everyday. CONDITION: Advanced/recurrent breast cancer PRIMARY OUTCOME: clinical benefit rate SECONDARY OUTCOME: response rate, time to progression, time to treatment failure, adverse events, presictive factor INCLUSION CRITERIA: 1. The case signed informed consent of the patients for the registration 2. The case confirmed by pathological diagnosis 3. postmenopausal women with breast cancer (not less than 30 year old) 4. The case who had progressive disease during or after the treatment of non‐steroidal aromatase inhibitors 5. The case with measurable metastatic / recurrent site or evaluable bone metastasis 6. The case with ER positive and/or PgR positive 7. The case that survival more than six months is anticipated 8. The case with PS 0 or 1, additionally the case with PS 2 only by bone metastasis 9. The case with a satisfactory function of a heart/liver/kidney/bone marrow and to satisfy the next condition Hb: more than 8g/dl AST(GOT), ALT(GPT): Less than 2.5 times of the normal value upper limit of the institution