Postmenopausal, hormone-receptor positive and primary breast cancer
Conditions
Interventions
Letrozole 2.5mg p.o. daily and Cyclophosphamide 50mg p.o. daily for 24 weeks
Sponsors
Japan Breast Cancer Research Group (JBCRG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Operable primary breast cancer(T2-4 N0-1 M0: at first diagnosis). 2.Histological confirmed invasive breast cancer by biopsy. 3.Estorogen receptor(ER) positive by Immunohistochemistry(IHC; >=10%). 4.Postmenopausal women and >=60 years old 5.Measurable region 6.Adequate major organ function; WBC >= 3,000/mm3 <= 12,000/mm3 or ANC >= 1,500/mm3 PLT >= 100,000/mm3 Hb >= 9.5 g/dl AST, ALT <= 1.5 x ULN T. Bil <= 1.25 x ULN Serum Cr. <= 1.5 Nomal ECG EF >= 60% 7.ECOG preformance status (P.S.): 0 and 1 1. 8.Written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy or endocrine therapy 2. Under treatment by medicines with the possibility to affect the state of the sex hormone (hormone replacement therapy or raloxifene, etc) 3. Active double cancer 4. Inflammatory breast cancer 5. Bilateral breast cancer 6. History of drug-hypersensitivity 7. Under treatment of investigational new drug for other disease except breast cancer 8. Mental disease 9. Patient judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological CR rate, Breast Conserving Surgery rate, Safety, Disease- free survival and Overall survival | — |
Countries
Japan
Contacts
Public ContactKatsumasa Kuroi
Japan Breast Cancer Research Group (JBCRG) Head Office
Outcome results
None listed