advanced or metastatic breast cancer
Conditions
Interventions
Cyclophosphamide:600 mg / m2, day1 nab-paclitaxel:80-150 mg / m2, day1,8,15 every 3 weeks
Sponsors
Mitsui Memorial Hospital Department of Breast Endocrine Surgery
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histrogical confirmed inoperable and metastatic breast cancer 2)HER2 negative confirmed by IHC or FISH 3)At least one measurable lesion 4)Performance status of 0 or 1 5)Age are 20-75 years old 6)Required baseline laboratory date within 14 days WBC>=4000/mm3 Neu>=2000/mm3 Hb>=9.0g/dL Plt>=100000/mm3 T-Bill=<1.5mg/dL AST<=100IU/L ALT<=100IU/L Cr<=1.2mg/dL 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Received a taxane within 6 months in neoadjuvant or adjuvant chemotherapy before study treatment 2)Received chemotherapy for metastatic breast cancer (more than one regimen) 3)Pre-treatment paclitaxel, docetaxel, nab-paclitaxel for metastatic breast cancer 4)Received endocrine therapy within 1 week of the study treatment 5)Received irradiation within 2 weeks of the study treatment 6)Received surgery within 4 weeks of the study treatment 7)With symptomatic brain metastases 8)With grade2 or grater peripheral neuropathy, myalgia, arthralgia 9)Requiring pleural effusion, peritoneal effusion, pericardial effusion by drain 10)Undergoing (oral or intravenous) systemic continuous steroids administration 11) With serious complications (active infection, pulmonary fibrosis, diabetes, heart disease, renal failure, hepatic failure, B hepatitis, C hepatitis, HIV, etc.) 12) With a history of hypersensitivity for nab-paclitaxel, paclitaxel, albumin , cyclophosphamide and undergoing pentostatin administration, with serious bone marrow suppression, infectious diseases 13)With active double cancer 14) Pregnant or possibility of pregnant 15)Patients judged by the investigator as unfit to be enrolled in the study the study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine maximum tolerated dose and recommended dose | — |
Countries
Japan
Outcome results
None listed