Breast cancer
Conditions
Interventions
capecitabine:10mg/m2 po, bid for 14days followed by 1 week off lapatinib: 1250mg/body po, dayly both drugs continue until the disease progress or adverse events become intolerable
Sponsors
Kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Women with a histopathological diagnosis of invasive breast carcinoma 2.Inoperable or recurrent breast cancer 3.HER2 positive breast cancer 4.Previous treatment with anthracyclines and trasuzumab 5.no previous treatment with capecitabine 6.patients who received less than 2 regimen of chemotherapy 7.Previously untreated with HER2 inhibitor other than trasuzumab (lapatinib is included) 8.Having measurable lesions 9.The tumor preserved can be offered for biomarker studies 10.Aged 20 or over 11.Performance Status(ECOG scale):0-1 12.Off-therapy period prior to the study: >=14 days 13.Adequate organ functions confirmed by blood tests taken conducted within 14 days before registration leukocyte>=3000mm3 or neutrophil>=1500mm3 hemoglobin>=9.0g/dL platelet count>=100,000/mm3 AST,ALT<=more than 3 times ULN total bilirubin=< more than 1.5 times ULN serum creatinine<=1.5mg/dL ejection fraction=>50% 14.Oral intake is possible 15.Written informed consent
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactation women, or women with suspected pregnancy 2.Patients who suffer malabsorption syndrome or disease affecting gastro intestinal function, or resection or stomach or small intestine, or ulcerative colitis 3.Coexistence malignant tumor other than breast cancer or a history of such tumor within 5 years of the beginning of this study 4.Patients who has not recovered from previous cancer treatment to less than G1 toxicity 5.Previous or current history of interstitial pneumonia 6.Active or poorly controlled infectious diseases 7.Severe psychiatric disorder 8.Poorly controlled or symptomatic angina pectoris, arrhythmia or congestive heart failure 9.Symptomatic CNS metastasis 10.Meningitis carcinomatosa 11.History of immediate or delayed hypersensitivity reaction to the compounds similar to both capecitabine and lapatinib 12.Patients judged by the investigator to be unfit for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between PFS and expression levels of p95HER2 and PTEN protein and PIK3CA gene mutation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between above 3 biological markers and following clinical indicators, i.e. tumor regression, clinical benefit, overall survival and adverse events | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group Exective office
Outcome results
None listed