Breast Cancer
Conditions
Interventions
After 4 course of Docetaxel and FEC, surgical resection is carried out. Docetaxel Docetaxel 75 mg/m2 is administered intravenously at day 1. One course is consisted by 3 weeks and repeated to 4 c
Sponsors
Department of Breast Surgical Oncology, Showa University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed primary breast cancer. 2) Clinical stage T1c-3 N0 M0 or T1-3 N1 M0 3) expected to radical cure by operation and neoadjuvant chemotherapy 4) has measurable region 5) Age more than 20 years old 6) no prior surgery, radiation, chemotherapy and endcrinethrapy 7) Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC more than 3500 /mm3 and less than 12,000 /mm3 Neu more than 2000 / mm3 Plt more than 100,000/mm3 T-Bil less than 2 times ULM AST less than 100 IU/L ALT less than 100 IU/L Cre less than 1.5 mg/dL 8) ECOG performance status is 0 to 2 9) Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1) History of sever hypersensitivity 2) Her 2 overexpression (3+ by IHC stain or 2+ and FISH positive) 3) Active other malignancies 4) Severe complications (infection, diarrhea, intestine on the paralyzed, and ileus which affect to treatment, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction within 6 months, heart failure interstitial pneumonia or pulmonary fibrosis, cerebrovascular accident etc.) 5) has brain metastasis with symptoms 6) has psychological illness which became a problem in practice 7) received transfusion within 2 weeks because of bleeding in gastrointestinal tract 8) sever bone suppression, renal dysfunction, and liver dysfunction 9) sever pleural effusion or ascites fluid 10) water diarrhea at registration 11) has infection or fever which suspected of infection 12) history of hypersensitivity to Nab-paclitaxel, paclitaxel or albumin 13) pregnant or possibility of pregnant 14) history of sever hypersensitivity to docetaxel or polysorbate-containing product 15) Patients judged inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is to evaluate the pathological CR rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is to evaluate the Clinical response rate, pathological response rate, breast conserving rate, and safety. | — |
Countries
Japan
Contacts
Public ContactTakashi Kuwayama
Showa University Department of Breast Surgical Oncology
Outcome results
None listed