Breast Cancer
Conditions
Interventions
Group A: Anastrozole (1mg/day) is administratedd orally on days 1-21 until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(+) Breast cancer
Group B: Anastrozole (1mg/day) is
Sponsors
Department of Breast and Thyroid Surgery, Kawasaki Medical School
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed Breast Cancer 2) Estrogen Respecter positive (10% cut off) 3) Performance Status (ECOG) 0-2 4) Measurable disease 5) Without prior chemotherapy nor use of Anastrozole 6) Adequate organ functions 7) Estimated life expectancy of at least 3 months 8) Postmenopausal 9) Oral intake is possible 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) concomitant malignancy 2) patient with marked infection 3) patient with marked fever and suspected infection 4) patient with metastasis to CNS 5) complications including ischemic heart disease 6) Active gastrointestinal ulceration 7) Serious Neuropathy 8) Anarmnesis of drug allergy 9) Severe Bone marrow suppression 10) serious renal function disturbance 11) serious liver function disturbance 12) taking other fluoropyrimidine derivatives 13) Under treatment with flucytosine 14) Not suitable for participating in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Disease free survival (DFS), Adverse events, Examination of the relevance of 5-FU relative factors (thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP), orotate phosphoribosyl transferase (OPRT) mRNA) and HER2 profile with efficacy, Clinical benefit | — |
Countries
Japan
Contacts
Public ContactKatsuhiro Tanaka
Kawasaki Medical School Department of Breast and Thyroid Surgery
Outcome results
None listed