UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of Bevacizumab plus Paclitaxel followed by Eribulin maintenance therapy in patients with HER2-negative metastatic breast cancer.
Acronym	A phase II study of Eribulin maintenance therapy in patients with HER2-negative metastatic breast cancer.
Scientific Title	A phase II study of Bevacizumab plus Paclitaxel followed by Eribulin maintenance therapy in patients with HER2-negative metastatic breast cancer.
Scientific Title:Acronym	A phase II study of Eribulin maintenance therapy in patients with HER2-negative metastatic breast cancer.
Region	Japan

Condition
Condition	HER2-negative metastatic breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the efficacy and safety of Eribulin maintenance therapy in patients who did not have progressive disease after receiving treatment with Bevacizumab plus Paclitaxel in patients with metastatic HER2-negative breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Time to Treament Failure
Key secondary outcomes	Progression Free Survival/ Objective Response Rate/ Overall Survival/ Safety/ FACT-GOG-NTX

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients were included in the run-in phase (three cycles of Bevacizumab plus paclitaxel). After induction chemotherapy, patients who did not have progressive disease receive Eriburin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Female
Key inclusion criteria	1)female patients who were histologically or pathologically confirmed as breast cance 2)The patient who fills following either about diagnosis of transition and recurrent breast cancer -I have a distant metastases that do not surgery at the time of the first visit -After treatment (after surgery and the before and after treatment) is a breast cancer that has progressed or recurrence at distant metastasis. However, local recurrence (operated side of upward subclavian edge, downward costal arch, inside sternum midline, outside refers to the chest wall is surrounded by latissimus dorsi leading edge) is excluded. Even in local recurrence, to qualify if they are a surgery outside in diffuse lesions, etc. 3)aged more than 20years and less than 75 years 4)ECOG PS of 0-2 5)having measurable lesion according to RECIST 6)adequate organ functions confirmed with following major examination: neutrophil count more than 1500/mcl platelet count more than 80,000/mcl hemoglobin more than 9.0g/dL AST,ALT less than 2.5 times the upper limit of nomal (ULN) AST,ALT of the patient with the metastasis to liver less than 5.0 times the upper limit of nomal (ULN) total bilirubin less than 1.5 times the upper limit of nomal (ULN) serum creatinine less than 1.5 times the upper llimit of nomal (ULN) 7)Persistent Grade <=1 sensory neuropathy at enrollment 8)HER2 negative disease 9)life expectancy of at least 3 months from enrolment 10)no problem in clinical at electrocardiogram 11)no prior therapy with eribulin, paclitael and bevacizumab 12)obtained written informed consent
Key exclusion criteria	1)having systemic infection with a fever of 38 degrees or more 2)protocol treatment of drug, and a history of hypersensitivity to the solvent 3)patients with brain metastases in need of treatment to the brain hypertension and emergency brain radiation 4)patients with following serious complication ischaemic heart disease or heart disease such as arrhythmia not controllable by treatment myocardial infarction < 6 months prior to study entry hepatic cirrhosis interstitial pneumonia or pulmonary fibrosis bleeding tendency Uncontrolable hypertension Uncontrolable proteinuria 5)having active double cancer 6)patients with a history of radiation therapy to the measurable lesions 7)history of mental disorder, a central nervous system damage, and cerebral blood vessel neuropathy 8)pregnancy, breast-feeding or women with childbearing potential 9)patients undergoing continuous systemic administration of steroids 10)HBs antigen is positive 11)judged by the investigator not to be appropriate for the study
Target sample size	53

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun Ninomiya
Organization	Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Secretariat Division (Ninomiya hospital)
Zip code
Address	491-6 shineicho, soka-shi, saitama-shi
TEL	048-941-2223
Email	jninomiya@grape.plala.or.jp

Public contact
Name of contact person	1st name Middle name Last name Kenichi Inoue
Organization	Saitama Cancer Center
Division name	Division of Breast Oncology
Zip code
Address	780, Komuro, Ina-machi, Kita-Adachi-gun, Saitama, Japan
TEL	048-722-1111
Homepage URL	http://www.sbccsg.org/
Email	ino@cancer-c.pref.saitama.jp

Sponsor
Institute	Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

Funding Source
Organization	Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	National Cancer Center Research and Development Fund, Health and Labour Sciences Research Expenses for Commission,and AMED.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	埼玉県立がんセンター（埼玉県），二宮病院（埼玉県），さいたま赤十字病院（埼玉県），春日部メディカルセンター（埼玉県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://doi.org/10.1186/s12885-018-4556-6
Number of participants that the trial has enrolled	51
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2018 Year 06 Month 20 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 12 Month 16 Day
Last modified on	2019 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018577