Luminal B (HER2-negative) primary breast cancer
Conditions
Interventions
After 12 cycles of weekly paclitaxel followed by 4 cycles of AC (or EC), surgical resection is carried out.
After 12 cycles of weekly paclitaxel plus anastrozole followed by 4 cycles of AC (or EC) pl
Sponsors
Hamamatsu Breast Cancer Team
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Female patients with histologically confirmed invasive breast cancer 2)Any T-Stage 3)HER2-negative 4)Either ER -positive or PgR-positive 5)Either Ki67-LI>=14% and NG>=2 or NG=3 regardless of Ki67-LI 6)No significant abnormal EKG 7)No prior treatment for breast cancer 8)No history of breast cancer and no synchronous bilateral breast cancer 9)ECOG PS 0-1 10)Sufficient organ function confirmed with following major examination WBC>=3000/mm3 Plt>=100000/mm3 Hb>=9.0g/dL T-Bil<=1.5mg/dL AST,ALT<=2.5 times ULN Cre<=1.5mg/dL No concurrent treatment for cerebral infarction at the registration. No history of myocardial infarction and congestive heart failure. No need for treatment of ischemic heart disease and valvular disorder 11)No distant metastasis 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Serious drug hypersensitivity 2)Pregnant or lactation women, or women with suspected pregnancy 3)Other any cancer 4)Other severe complications 5)Severe mental disorders 6)Active bleeding of digestive tract 7)Serious myeloablation,renal insufficciency,liver failure 8)Massive hydrothorax or ascites 9)Diarrhea 10)Active infection 11)Under treatment with continuous systemic steroid, estrogen or selective estrogen receptor modulators 12)Active participant in any other clinical trial for breast cancer 13)Not suitable for participating in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical response rate adverse events histological therapeutic effect breast conserving rate Health related quality of life | — |
Countries
Japan
Contacts
Public ContactRyoichi Matsunuma
Hamamatsu University School of Medicine First Department of Surgery
Outcome results
None listed