advanced or recurrent breast cancer patients.
Conditions
Interventions
Docetaxel
Sponsors
Okayama University Hospital Center for Innovative Clinical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients aged 20 years or older at providing informed consent (2)Patients with histopathological diagnosis of breast cancer (3)Patients with recurrent breast cancer that is inoperable, unsuitable for radiation therapy or with stage IV breast cancer, regardless of whether they have a measurable lesion (4)Patients with ECOG performance status (PS) 0-1 at screening (5)Patients with functional organs as defined by the following laboratory test values at screening Hemoglobin: 8.0 g/dL or more Neutrophil count: 1,500/mm3 or more Platelet count: 100,000/mm3 or more AST (GOT), ALT (GPT): Twice the upper limit of the sites reference range or less Total bilirubin: 1.5 mg/dL or less Blood alkaline phosphatase: 2.5 times the upper limit of the sites reference range or less Serum creatinine: 1.0 mg/dL or less (6)Patients not within 2 weeks after surgery, 4 weeks after the last dose of prior chemotherapy or hormone therapy, or 2 weeks after the last dose of prior radiation therapy (7)Patients with a life expectancy of at least 3 months (8)Patients without excessive expression of HER2. However, patients with excessive expression of HER2 can participate in the trial if anti-HER2 therapy is not indicated (9)Patients in whom all clinically significant toxicity related to the prior anti-cancer therapies (surgery, radiation therapy, anticancer drug) have resolved to CTCAE (v 4.0) grade 1 or below (10)Patients who provided written informed consent of their own to participate in this trial
Exclusion criteria
Exclusion criteria: (1)Patients with a history of hypersensitivity to Docetaxel, alcohol or any drug product containing Polysorbate 80 (2)Patients with a mental disease or patients who are incapable of participating in the trial due to psychiatric symptoms (3)Patients with any uncontrollable infection (e.g., fungi, virus, bacteria) (4)Patients with unstable or untreated metastasis in the central nervous system (5)Patients with any uncontrolled heart disease including cadiomyopathy, NYHA grade III or IV heart diseases, arrhythmia, unstable angina and myocardial infarction (6)Patients with a history of treatment with Docetaxel for advanced or recurrent breast cancer. However, patients with recurrent disease can participate if the disease recurred at least 6 months after receiving the last dose of Docetaxel in a pre- and/or post-operative adjuvant chemotherapy (7)Patients who cannot tolerate pretreatment with Dexamethasone because steroids are clinically contraindicated (8)Patients with a history of or concurrent malignant tumor (9)Patients positive for anti-human immunodeficiency virus antibody, those with active chronic type B or type C hepatitis. (10)Patients with concurrent peripheral neuropathy of CTCAE (v 4.0) grade 2 or higher (11)Women who are pregnant, possibly pregnant or are lactating (12)Premenopausal, possibly pregnant female patients or fertile male patients who do not agree to practice contraception using medically approved methods from 2 weeks before the start of administration of the investigational product to 120 days after the completion of administration of the investigational product (13)Patients who cannot continue the treatment under hospitalization for at least 15 days, beginning from the start of administration of the investigational product in the first course (14)Patients otherwise unsuitable for this clinical trial in the opinion of the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics pharmacodynamics efficacy | — |
Countries
Japan
Contacts
Public ContactTaizo Hirata, M.D., Ph.D.
Okayama University Hospital Center for Innovative Clinical Medicine
Outcome results
None listed