HER2 negative breast cancer
Conditions
Interventions
Bavacizumab 10 mg/m2 and Paclitaxel 90 mg/m2
Sponsors
Setouchi Breast Project Comprehensive Support Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent 2) Female >=20 years old 3) Histologically or cytologically confirmed breast cancer 4) Relapsed patients who have previously treated (neo)adjuvant treatment with taxane (paclitaxel, docetaxel and nab-paclitaxel) at any DFI 5) HER2 negative* *FISH negative or IHC <=2+; IHC =2+ has to be tested by FISH for negative status 6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 7) Life expectancy of at least 3 months 8) With measurable lesion defined by RECIST version 1.1 with stimative diseases, excluding lesion received radiotherapy 9) No previous chemo therapy for metastatic or inoperable breast cancer, hormone therapy is acceptable 10) Sufficient function of main organ and bone marrow met the following criteria within 2 weeks from registration: 1.Neutrophil counts, 1,500/mm3 or over. 2.Platelet counts, 100,000/mm3 or over. 3.Total bilirubin, 1.5mg/dl or less. 4.AST and ALT, x 3 of upper limit of normal (ULN) or less. 5.Serum creatinin, x 1.5 of ULN or less. 6.Proteinuria <=1+
Exclusion criteria
Exclusion criteria: 1) Prior therapy with bevacizumab 2) Hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell derived products or other recombinant humanized antibodies 3) Symptomatic brain metastasis 4) Women who is pregnant, lactating or declined contraception 5) Patients with a non-healing wound or fracture 6) Uncontrolled hypertension (SBP>150 mmHg, DBP>100 mmHg) 7) Patients receiving anticoagulant therapy within 10 days prior to registration (aspirin <=325 mg/day is allowed.), or patients need anticoagulant therapy during study 8) Symptomatic congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction within 12 months prior to study entry 9) Idiopathic pulmonary fibrosis, interstitial lung disease 10) Baseline left ventricular ejection fraction (LVEF) > 50% measured by echocardiography 11) Current or previous history (within 12 months) of symptomatic cerebrovascular disease 12) Current or previous history (within 12 months) of deep vein thrombosis or pulmonary embolism 13) Current or previous history (within 12 months) of GI perforation 14) Synchronous or metachronous tumors with <5 years disease-free period 15) Patients ineligible to the study based on decision of attending physician or site principal investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Overall survival, Time to treatment failure, Clinical benefit rate, Efficacy analysis by taxane, Safety profile | — |
Countries
Japan
Contacts
Public ContactTaira Naruto
Setouchi Breast Project Comprehensive Support Organization Clinical trial committee
Outcome results
None listed