women with HER2-positive and hormone receptor-positive breast cancer
Conditions
Interventions
Eligible premenopausal women receive tamoxifen 20mg/d orally and trastuzumab is given with a loading dose of 4 mg/kg
subsequent doses are 2 mg/kg every week. In addition, paclitaxel is given at a dose of 80 mg/m2
every week for 12 weeks. Eligible postmenopausal women receive letrozole 2.5mg/d orally and trastuzumab is given with a loading dose of 4 mg/kg
every week for 12 weeks.
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed invasive breast cancer 2. ER and or PgR-positive, HER2-positive 3. Measurable disease 4. Stage I , II or III 5. Age at 20 or older and at 75 or younger. 6. Performance status 0 or 1 7. Untreated breast cancer 8. Meet the cirteria of baseline labolatory parameters as below. 1) WBC 3500/mm3 or more, 10000/mm3 or less, Plt 100,000/mm3 or more, Hb 10g/dl or more 2) T.Bil 1mg/dl or less, GOT 60 IU/L or less, GPT 60 IU/L or less 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Other active malignancies 2. Hemorrhagic diathesis 3. History of cardiac infarction, valvular diseases of the heart and severe cardiac disfunction 4. Liver cirrhosis 5. Other medical conditions that could limit a patient's ability to undertake study therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical response rate, tumor reduction rate | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological CR rate, adverse event, breast conserving rate, relapse free survival | — |
Countries
Japan
Contacts
Public ContactTetsu Hayashida
Keio University School of Medicine Department of Surgery, breast group
Outcome results
None listed