UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015971 |
|---|---|
| Receipt number | R000018577 |
| Scientific Title | A phase II study of Bevacizumab plus Paclitaxel followed by Eribulin maintenance therapy in patients with HER2-negative metastatic breast cancer. |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2019/12/20 18:51:05 |
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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
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/
ino@cancer-c.pref.saitama.jp
Sponsor or person
Institute
Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018577
| Research Plan | |
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