Breast Cancer
Conditions
Interventions
letrozole 2.5mg/day, 24 weeks
Sponsors
Department of Breast and Endocrine Surgery, Hyogo College of medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Stage2A, 2B, 3A, 3B breast cancer 2) Histologically confirmed breast cancer 3) Postmenopausal women 4) ER- and/or PgR-positive (10% or more cancer cells were positive) 5) HER2-psotive (IHC score 3, or IHC score 2+ and FISH-positive) 6) 75 years old or less 7) Performance status 0 or 1 8) Breast cancers with evaluable lesion 9) Sufficient organ function meeting following criteria: (1) Leukocyte > 3000 mm3 or Neutrophil >1500 mm3 (2) Hemoglobin >9.0g/dL (3) Platelet >100000 mm3 (4) AST (GOT) and ALT(GPT) < 2.5 x upper limit of normal (ULN) (5) Serum total bilirubin <1.5 mg/dL (6) Serum creatinine <1.5 mg/dL (7) Normal electrocardiogram (8) LVEF is >55% measured by echocardiography or MUGA scan 10) No finding of pneumonitis or fobrosis by Chest CT or X-ray 11) MRI or CT of the breast must be done pre- and post-chemotherapy 12) No prior treatment for breast cancers 13) Signed written informed consent
Exclusion criteria
Exclusion criteria: 1) Inflammatory breast cancer 2) Bilateral breast cancers without DCIS or ICIS 3) With multiple cancers diagnosed with 5 years 4) With uncontrollable hypertension, angina pectoris, congestive heart failure 5) With severe complication including infection or uncontrolled diabetes mellitus 6) With viral hepatitis (HBs antigen- or HCV antibody-positive) 7) Patients treated with endocrine therapy 8) Infection or possible infection associated with clinical symptoms such as fever 9) With severe edema 10) With severe mental disorder 11) Cases who physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate | — |
Countries
Japan
Contacts
Public ContactYasuo Miyoshi
Hyogo College of medicine Breast and endocrine Surgery
Outcome results
None listed