Breast cancer
Conditions
Interventions
Docetaxel 75mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles.
Sponsors
Kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically-confirmed invasive breast cancer 2. Age between 20 and 70 years 3.HER2-negative tumor 4.ECOG performance status 0 to 1 5.No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer 6 .Sufficient organ function (e.g. bone marrow, cardiac, liver and renal) 7. No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan. 8. Presence of evaluable primary lesion before and after treatment by CT, MRI or ultrasound. The evaluation must be based on the same modality. 9. Patient who is considers onsidered eligible for neoadjuvant chemotherapy 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Bilateral breast cancer 2. Male breast cancer 3. With active another cancer 4. History of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 5. History of hypersensitivity reaction to any drugs which are to be used in this study 6. Uncontrolled underlying medical conditions 7. Patients who need concurrent treatment by corticosteroids except for premedication 8. Severe psychiatric disorders 9. Pregnant or lactation women, or women with suspected pregnancy 10. Patients judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast-conserving rate Pathological complete response rate Safety Disease free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group Executive office
Outcome results
None listed