breast cancer
Conditions
Interventions
None listed
Sponsors
Dept. of Endocrine & Breast Surgery, Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females with breast cancer which is confirmed to be invasive breast cancer by histological or cytological examination. 2. Advanced/reccurent HER2-positive breast cancer patients with clinical stage IIIb, IIIc, or IV. 3. Patients not using chemo agents or trastuzumab as 1st line therapy of advanced/reccurent breast cancer. 4. Patients with a lesion allowing RECIST (ver.1.1) measurement by imaging examinations such as CT or MRI. 5. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods. 6. Patients with a performance status (ECOG) of 0, 1, or 2 7. Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan). 8. Patients with adequately maintained organ functions and fulfilling the following conditions within 7 days before registration. (1)Neutrophil>=1,500/mm3 (2)Platelet>=100,000/mm3 (3)Hb>=9.0g/dL (4)T-BIL<=2.0mg/dL (5)AST, ALT <=100IU/L (6)Serum creatinine <= 1.5mg/dL 9. Patients expected to survive for 6 months or more. 10. Patients not have QTc prolongation by electrocardiogram (QTc: less than 470msec). 11. Patients who provided written informed consent by themselves in principle to participate in this trial.
Exclusion criteria
Exclusion criteria: 1. Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer. 2. Patients with a past history of interstitial pneumonitis, pulmonary fibrosis or severe emphysema. 3. Patients with brain metastases treatment is required at the time of registration. 4. Patients with serious co-morbidities (1)Uncontrolled diabates (2)Uncontrolled hypertension (3)Myocardial infarction within 24 weeks prior to registration, unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia requiring medication. (4)Ischemic heart disease, arrhythmias, valvular disease requiring medication. (5)Liver dysfunction(jaundice) (6)Renal dysfunction (7)Active infection or fever suspicious of infection. (8)Other serious complications 5. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception. 6. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical benefit | — |
Countries
Japan
Contacts
Public ContactKoichi Sakaguchi
Kyoto Prefectural University of Medicine Endocrine & Breast Surgery
Outcome results
None listed