metastatic breast cancer
Conditions
Interventions
Treatment with nab-Paclitaxel (260mg/m2, q3w), Pertuzumab (840mg followed by 420mg, q3w) and Trastuzumab (8mg/kg followed by 6mg/kg, q3w)
Sponsors
The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer 2.Primary or metastatic region is HER2 positive: either 3+ over-expression by IHC or positive by FISH 3.With or without evaluable lesion 4.Female between 20 and 75 years old 5.Baseline left ventricular ejection fraction (LVEF) is >50% measured by echocardiography or MUGA scan. 6.PS: 0-2 (ECOG) 7.Expected survival time more than 6 months 8.Signed written informed consent
Exclusion criteria
Exclusion criteria: 1.Without previous chemotherapy 2.With brain metastasis with symptom 3.With active another cancer 4.With uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 6 months, arrhythmia that need treat, valvular heart disease 5.With dyspnea at rest due to metastatic lung lesion 6.Insufficient organ function meeting following criteria Neutrophil <1500/mm2 Platelet <100000/mm2 Hemoglobin <8.0g/dL AST(GOT)>100IU/L (with liver function disorder by metastasis) ALT (GPT) >100IU/L (with liver function disorder by metastasis) Serum total bilirubin <2.0mg/dL Serum creatinine >2.0mg/dL or 177umol/L 7.With uncontrollable systemic disease (cardiovascular/pulmonary/metabolic, protracted wound healing, ulcer and bone fracture) 8.With uncontrollable hypercalcemia even by Bisphosphonate or denosumab 9.Pregnant or nursing women 10.Infection or possible infection associated with clinical symptoms 11.With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab. 12.Cases who physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to treatment failure | — |
Secondary
| Measure | Time frame |
|---|---|
| safety(after the first cycle) response rate (best effect) | — |
Countries
Japan
Contacts
Public ContactMasami Morimoto
The University of Tokushima Graduate School Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
Outcome results
None listed