Recurrent/advanced breast cancer patients with tumor which has relapsed after treatment of aromatase inhibitors
Conditions
Interventions
TOR: Toremifene (120mg) is orally administered once a day everyday.
FUL: Fulvestrant (500mg) is intramuscular injected, day 1, day 15, day 28, followed by every 28 days.
Sponsors
Department of Breast and Endocrine Surgery Graduate School of Medical Sciences, Kumamoto University
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. The case with active other malignancies 2. The case with past history of drug allergy or hypersensitivity 3. The case during pregnancy or lactation 4. The case with severe progressive situation with non-indication for the hormone therapy 5. The case judged inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, time to progression, time to treatment failure, adverse events, presictive factor | — |
Countries
Japan
Contacts
Public ContactYutaka Yamamoto
Kumamoto University Hospital Department of Breast Cancer Molecular Trageting Therapy
Outcome results
None listed