UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011020 |
|---|---|
| Receipt number | R000012902 |
| Scientific Title | Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer. |
| Date of disclosure of the study information | 2013/06/24 |
| Last modified on | 2017/11/30 18:09:47 |
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Basic information
Public title
Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Acronym
Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Scientific Title
Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Scientific Title:Acronym
Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Region
| Japan |
Condition
Condition
Advanced/recurrent HER2-positive breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate Efficacy and Safety the combination of Eribulin and Trastuzumab in Patients with advanced/recurrent HER2-positive breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Objective Response Rate
Key secondary outcomes
Clinical Benefit Rate
Overall Survival
Progression Free Survival
Time to Treament Failure
Safety
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
Eribulin 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Administration trasutuzumab every 3week with a starting dose of 8mg/kg followed by 6mg/kg as the second and subsequent doses.
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 patient who were histologically confirmed as breast cancer
2)previously treated with combination chemotherapeutic and anti-HER2 therapy
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/microL
platelet count more than 100,000/microL
hemoglobin more than 8.0g/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)obtained written informed consent
Key exclusion criteria
1)having systemic infection with a fever of 38 degrees or more
2)pleural effusion, ascites, or pericardial fluid requiring drainage
3)brain metastasis with clinical symptoms
4)patient 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
5)having active double cancer
6)HER2 over-expressed
7)pregnancy, breast-feeding or women with childbearing potential
8)judged by the investigator not to be appropriate for the study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Saito |
Organization
Saitama Red Cross Hospital
Division name
Department of breast surgery
Zip code
Address
8-3-33, Kamiochiai, Cyuo-ku, Saitama-city, Japan
TEL
048-852-1111
tsaito@jcom.home.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kai |
Organization
Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Division name
Secretariat Division (Shintoshin Ladies' Mammo Clinic)
Zip code
Address
3F Capital Building ,4-261-1 kishiki-cho, omiya-ku, saitama-shi
TEL
048-600-1722
Homepage URL
http://www.sbccsg.org/
toshikai@sbccsg.org
Sponsor or person
Institute
Sairtama Breast Cancer Clinical Study Group (SBCCSG)na
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
さいたま赤十字病院，埼玉県立がんセンター，埼玉社会保険病院，自治医大さいたま医療センター，赤心堂病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012902
