Primary breast cancer
Conditions
Interventions
4 cycles of Anthracycline base adjuvant chemotherapy followed by 4 cycles of Nab-paclitaxel. The regimen for Nab-paclitaxel is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
Sponsors
Saitama Breast Cancer Clinical Study Group(SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed breast cancer. 2) Stage I, IIA, IIB, IIIA 3) The adjuvant chemotherapy is necessary 4) Age more than 20 years and less than 70 years. 5) ECOG performance status of 0 to 1 6) Within 6 weeks after surgery 7) Adequate major organ function. 8) Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC more than 3000 /mm3 Neu more than 1500 / mm3 Plt more than 100,000/mm3 AST less than 2.5 times ULN ALT less than 2.5 times ULN T-Bil less than 1.5mg/dl Cre less than 1.5mg/dl Cardiac function normal ECG 9) Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1) HER2 is positive by surgical specimen. 2) Pregnant or lactation women. 3) History of other malignancies within the last 5 years. 4) History of bilateral breast cancer 5) History of serious allergy 6) Patients judged by the investigator to be unfit to be enrolled into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Overall survival Disease free survival Relation between Relative Dose Intensity (RDI) of Nab-Paclitaxel and Disease Free Survival ratio | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group(SBCCSG) Secretariat Division (Shintoshin Ladies' Mammo Clinic)
Outcome results
None listed