Breast cancer
Conditions
Interventions
After 6 cycles of induction treatment with paclitaxel plus bevacizumab, continue maintenance treatment with paclitaxel plus bevacizumab until disease progression, then perform endocrine treatment unti
Sponsors
CAPTURE Clinical Trial Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Pathological or cytological confirmed breast cancer 2)Postmenopausal inoperable breast cancer with metastatic disease or recurrence 3)HER2 negative(IHC 0, 1, 2 or ISH<2.0) 4)Performance Status 0-2 5)Evaluable lesion by RECIST(eligible in case with bone metastasis alone or carcinomatous fluid retention) 6)Recurrence during adjuvant endocrine treatment, or within 6 months after finishing of adjuvant endocrine treatment. Disease progression on endocrine treatment for inoperable or recurrence. Recurrence during adjuvant endocrine treatment, or within 6 months after finishing of adjuvant endocrine treatment Disease progression on endocrine treatment for inoperable or recurrence. Not adopt this criteria in multiple organs (lung or liver) metastasis 7)None or 1 regimen of prior chemotherapy for metastatic breast cancer 8)No influence of prior treatment 9)Maintained organ function 10)More than 3months life expectancy 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Prior treatment of bevacizumab 2)Allergy to paclitaxel 3)Brain metastasis with risk of bleeding 4)Pregnancy, nursing 5)Active hepatitis 6)Non-healing severe wound or traumatic bone fracture 7)Pleural effusion, ascites or pericardial effusion that requires drainage 8)Uncontrollable hypertension 9)Usage of antithrombotic agents 10)Continuous administration of corticosteroid 11)Symptomatic congestive heart failure, unstable angina, arrhythmia requiring treatment, myocardial infarction within 1 year 12)Idiopathic pulmonary fibrosis or interstitial pneumonitis 13)Symptomatic cerebral vascular disturbance, or its history within 1 year 14)Deep venous thrombosis or pulmonary infarction, or its history within 1 year 15)Perforation of digestive tract, or its history within 1 year 16)Plan of surgery with risk of bleeding Double cancer within 5 years of disease free interval 17)Symptomatic dysfunctional peripheral neuropathy 18)Active peptic ulcer 19)Body temperature more than 38C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival between randomization and first progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival between randomization and second progression Progression free survival between first registration and first progression Progression free survival between first registration and second progression Response rate of induction treatment Response rate of second treatment Overall survival since randomization Overall survival since first registration Safety Health Related QOL The related study defines as below in the another protocol Feasibility of biopsy Alteration of immunohistochemistry between primary and metastatic tumor Exploratory immunohistochemistry Whole exon sequencing of genome | — |
Countries
Japan
Contacts
Public ContactMichiko Yago
Secretariat of CAPTURE Clinical Trial Registration Center
Outcome results
None listed