Breast cancer
Conditions
Interventions
Gemcitabine:800-1250mg/m2 day1,8 nab-Paclitaxel:220-260mg/m2 day1 every 3 weeks
Sponsors
Tokyo-West Tokushukai Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed breast cancer 2) Inoperative metastatic or recurrent breast cancer 3) Patients with evaluable lesion 4) Age are 20-75 years old 5) Prior chemotherapy regimen for metastatic breast cancer until one 6) Adequate baseline organ and marrow function as defined below: hemoglobin: >=9.0 g/dL WBC count: >=4,000/mm3 neutrophil count: >=2,000/mm3 platelet count: >=100,000 mm3 total bilirubin: =<1.5 mg/dL AST(GOT): =<ULN x 2.5 ALT(GPT): =<ULN x 2.5 serum creatinine: =<1.5 mg/dL 7) ECOG performance status (PS) 0-1 8) Patients who have passed the following periods from previous treatment (1)Endocrinetherapy:7 days from the final administration (2)Adjuvant:6 months from the final administration (3)Chemotherapy:14 days from the final administration 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Inflammatory and bilateral breast cancer 2) HER2 positive confirmed by IHC or FISH 3) Active another cancer 4) History of hypersensitivity reaction 5) Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure 6) Neuropathy <= grade1 7) Radiation therapy for chest 8) Serious myelosuppression 9) Infection 10) Pregnant or possibility pregnancy or nursing woman 11) History of hypersensitivity for albumin 12) Physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determinate maximum tolerated dose and recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Response rate | — |
Countries
Japan
Contacts
Public ContactMasaru Iwai
Tokyo-West Tokushukai Hospital Department of Pharmacy
Outcome results
None listed