UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007113 |
|---|---|
| Receipt number | R000008381 |
| Scientific Title | Evaluation of efficacy and safety of combinationtherapy with trastuzumab and eribulin for HER2-positive inoperableness or metastatic breast cancer |
| Date of disclosure of the study information | 2013/12/31 |
| Last modified on | 2012/01/22 11:30:44 |
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Basic information
Public title
Evaluation of efficacy and safety of combinationtherapy with trastuzumab and eribulin for HER2-positive inoperableness or metastatic breast cancer
Acronym
Combination therapy of trastuzumab and eribulin
Scientific Title
Evaluation of efficacy and safety of combinationtherapy with trastuzumab and eribulin for HER2-positive inoperableness or metastatic breast cancer
Scientific Title:Acronym
Combination therapy of trastuzumab and eribulin
Region
| Japan |
Condition
Condition
inoperableness or metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of combinationtherapy with trastuzumab and eribulin for HER2 positive inoperableness or metastatic breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall Response Rate
Key secondary outcomes
Time to Treatment Failure
Progression-Free Survival
Overall Survival
Adverse event
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
Treatment with trastuzumab (8mg/kg followed by 6mg/kg, q3w, or 4mg/kg followed by 2mg/kg weekly) and eribulin (on day 1 and 8 every 3 weeks).
Continue to disease progression.
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)With serious drug allergy
(2) Systemic infection
(3)Control of pleural effusion,ascites and pericardial fluid
(4)Clinical symptoms with brain metastasis
(5) Severe complications
1) Control of bad heart disease
2) Myocardial infarction within 6 months
3) Cirrhosis
4) Between interstitial Pneumonitis and pulmonary fibrosis
5) Bleeding tendency
(6) Active cancer
(7) Pregnancy, breast feeding or wish of future bearing
(8) Long-term corticosteroid therapy
(9) Wide range of radiation therapy
(10)Refusal of blood transfusion
(11) Patients considered inappropriate by the study investigator
Key exclusion criteria
(1)With serious drug allergy
(2) Systemic infection
(3) Control of pleural effusion, ascites and pericardial fluid
(4)Clinical symptoms with brain metastasis
(5) Severe complications
1) Control of bad heart disease
2) Myocardial infarction within 6 months
3) Cirrhosis
4) Between interstitial Pneumonitis and pulmonary fibrosis
5) Bleeding tendency
(6) Active cancer
(7) Pregnancy, breast feeding or wish of future bearing
(8) Long-term corticosteroid therapy
(9) Wide range of radiation therapy
(10)Refusal of blood transfusion
(11) Patients considered inappropriate by the study investigator
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Oura |
Organization
Wakayama Medical University
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
Address
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
073-447-2300
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoji Oura |
Organization
Wakayama Medical University
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
Address
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
073-447-2300
Homepage URL
Sponsor or person
Institute
Wakayama Medical University Department of Thoracic and Cardiovascular Surgery
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 31 | 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
| 2011 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | 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
| 2012 | Year | 01 | Month | 22 | Day |
Last modified on
| 2012 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008381
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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