Primary breast cancer
Conditions
Interventions
Nab-Paclitaxel:180-260mg/m2 Cyclophosphamide:600mg/m2 If Her2 is overexpression Trastuzumab:1st time 8 mg/kg,2nd and subsequent 6 mg/kg Cycles are repeated every 3 weeks
Sponsors
Gunma Breast Clinical Conference Study Group(GBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed inoperable breast cancer with recurrence or metastasis. 2)Adjuvant or neo adjuvant chemotherapy for breast cancer must have been completed more than 12 months before registering in this study. Or prior chemotherapy for metastatic disease have been included Nab-paclitaxel. 3)Operation and radiation therapy and chemotherapy >= 2 weeks and Hormonal therapy and administrated Trastuzumab >= 4 weeks. 4)Age more than 20 years and less than 75 years At registration. 5)ECOG performance status of 0 to 2. 6)Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC more than 4,000 /mm3 Neu more than 2,000 / 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 7)Patients have enough organ function for study treatment. 8)No severe infectious disease 9)Life expectancy of more than 3 months 10)If Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive) use Trastuzumab together, they have over 50% of LVEF. 11)Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1)History of serious allergy for nab-paclitaxe, cyclophosphamide, paclitaxel or albumin 2)Patients who applied radiation therapy, adjuvant or neo adjuvant chemotherapy within 3 weeks before registraion 3)Serious complication. 4)Active other malignancies 5)Symptomatic brain metastasis 6)peripheral nerve disorder =>Grade2 7)Patients in pregnancy, at risk of pregnancy, 8)Patients judged inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate maximum tolerated dose to determine recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Safety | — |
Countries
Japan
Contacts
Public ContactJun Horiguchi
Gunma Breast Clinical Conference Study Group(GBCCSG) Secretariat Division (Thoracic Visceral Organ Surgery , Gunma University)
Outcome results
None listed