breast cancer
Conditions
Interventions
neoadjuvant chemotherapy and radiotherapy
Sponsors
Osaka Medical Center for Cancer and Cardiovascular Diseases
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) biopsy-proven invasive breast cancer 2) TNM classification: T2-T4, N0-2, M0 3) HER2-negative tumor 4) PS (ECOG): 0 or 1 5) Normal bone marrow, liver and renal function 6) Patients who have never received any treatment for breast cancer 7) Written informed consent is obtained
Exclusion criteria
Exclusion criteria: 1) past history of any invasive malignancy within the previous 5 years 2) past history of breast cancer or synchronous bilateral breast cancer 3) past history of radiotherapy for ipsilateral breast 4) Suspicious of allergy for radiotherapy 5) Suspicious of allergy for paclitaxel, 5FU, epirubicin or cyclophosphamide 7) Patients during uncontrollable diabetes or psychologic disorder 8) Patients who have grade3-4 neuropathy 9) Pregnant or breast-feeding 10) Any reason the physician believes that the patient is not appropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical response rate disease free survival rate of breast-conserving surgery adverse events | — |
Countries
Japan
Outcome results
None listed