Advanced/recurrent breast cancer
Conditions
Interventions
Daily oral administration of 120 mg (60 mg x 2 tablets) of toremifene and 25 mg/day of exemestane
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients who provided written informed consent by themselves in principle to participate in this trial 2. Postmenopausal females with breast cancer in whom the primary lesion was confirmed to be breast cancer by histological or cytological examination 3. Patients who showed recurrence during or after the administration of anastrozole or letrozole as postoperative adjunctive therapy or therapy for progression/recurrence 4. Patients not using other endocrine therapy or chemotherapy drugs after the completion of aromatase inhibitor administration 5. Patients with a lesion allowing measurement or only bone metastasis 6. ER(+) and/or PgR(+) patients 7. Patients expected to survive for 3 months or more 8. Patients with a performance status (ECOG) of 0, 1, or 2 9. Patients with adequately maintained heart/liver/kidney/bone marrow functions and fulfilling the following conditions (1) Hb level:  9g/d (2) AST(GOT), ALT(GPT):  2.5 times the normal limit at the institution
Exclusion criteria
Exclusion criteria: 1. Patients with active double cancer 2. Patients with life-threatening symptoms, extensive organ metastasis (1/3 of the organ), or brain metastasis 3. Patients with a past history of severe drug hypersensitivity 4. Pregnant or breastfeeding females 5. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical benefit | — |
Countries
Japan
Outcome results
None listed