Locally advanced or metastatic breast cancer
Conditions
Interventions
Treatment with Abraxane (260mg/m2, q3w) and trastuzumab (8mg/kg followed by 6mg/kg, q3w, or 4mg/kg followed by 2mg/kg weekly) +- pertuzumabu(840mg followed by 420mg). Continue to disease progression.
Sponsors
Department of Breast and Endocrine Surgery, Hyogo College of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer 2) With evaluable lesion 3) Female between 20 and 75 years old 4) Primary or metastatic region is HER 2 positive: either 3+ over-expression by IHC or positive by FISH 5) Patients who have passed the following periods from previous treatment in case of operation or radiation therapy, 21 days are needed. in case of endocrine therapy, 14 days from the final administration are needed. 6) PS: 0-1 (ECOG) 7) Baseline left ventricular ejection fraction (LVEF) is >50% measured by echocardiography or MUGA scan. 8) Sufficient organ function meeting following criteria: Leukocyte >=4000 mm3 Neutrophil >=2000 mm3 Platelet >=100000 mm3 Hemoglobin >=9.0g/dL AST (GOT) <=2.5 x upper limit of normal (ULN) ALT (GPT) <=2.5 x upper limit of normal (ULN) Serum total bilirubin <=1.5 mg/dL Serum creatinine <=1.5 mg/dL 9) Expected survival time more than 3 months 10) Signed written informed consent
Exclusion criteria
Exclusion criteria: 1) With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab. 2) With serious drug allergy 3) Pregnant or nursing women 4) With active another cancer 5) With widespread liver metastases or pulmonary lymphangitis with dyspnea 6) With brain metastasis with symptom 7) With uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 1 year, arrhythmia that need treat, valvular heart disease 8) Poorly controlled diabetes 9) With pulmonary fibrosis or pneumonitis 10) With dyspnea at rest (due to metastatic lung lesion and cardiovascular disease) 11) With pleural effusion, ascites, and pericardial effusion that need treat 12) Infection or possible infection associated with clinical symptoms such as fever 13) Patients have active hepatitis type B 14) Cases who physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, progression-free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactYasuo Miyoshi
Department of Breast and Endocrine Surgery Surgery
Outcome results
None listed