Primary breast cancer
Conditions
Interventions
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 or cytologically confirmed inoperable breast cancer with recurrence or metastasis. 2) At least one measurable lesion 3) Previously treated with taxanes (Eligible if taxanes are used in neo-adjuvant or adjuvant setting and completed less than one year before registration.) 4) Any treatment including chemotherapy >=4 weeks. Hormonal therapy and radiation therapy >= 2 weeks 5) Age more than 20years and less than 75 years. 6) ECOG performance status of 0 to 2. 7) 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 8) Patients have enough organ function for study treatment. 9) No severe infectious disease 10) Life expectancy of more than 3 months 11) Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1) Either of ER, PgR, HER2 is positive by surgical specimen. 2) Previously treated with Nab-paclitaxel. 3) Confirmed histologically HER2 positive. 4) History of serious allergy for paclitaxel or albumin 5) Serious complication. (intestinal paralysis, intestinal obstruction, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus) 6) Symptomatic brain metastasis 7) Active other malignancies 8) Severe psychiatric disorders 9) During pregnancy 10) Patients judged inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Clinical benefit rate Progression free survival Time to treatment failure overall survival Safety | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group(SBCCSG) Secretariat Division (Shintoshin Ladies' Mammo Clinic)
Outcome results
None listed