UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027165 |
|---|---|
| Receipt number | R000031130 |
| Scientific Title | A study to evaluate the efficacy of Eribulin retreatment in HER2 negative Metastatic Breast Cancer patients - Phase II study - |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2017/04/27 16:49:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to evaluate the efficacy of Eribulin retreatment in HER2 negative Metastatic Breast Cancer patients - Phase II study -
Acronym
Evaluation of Eribulin retreatment - Phase II study -
Scientific Title
A study to evaluate the efficacy of Eribulin retreatment in HER2 negative Metastatic Breast Cancer patients - Phase II study -
Scientific Title:Acronym
Evaluation of Eribulin retreatment - Phase II study -
Region
| Japan |
Condition
Condition
HER2-negative metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety for Eribulin retreatment in HER2 negative Metastatic Breast Cancer patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival(retreatment of Eribulin)
Key secondary outcomes
Objective Response Rate and 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
To reintroduce Eribulin for Metastatic Breast Cancer patients who received prior Eribulin treatment and had effect
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,Pathologically confirmed primary breast cancer
2,Inoperable or recurrent breast cancer
3,HER2-negative by IHC or FISH
4,ECOG performance status 0-2 at the registration
5,Metastatic Breast Cancer patients who received prior Eribulin treatment and had effect(SD or more)
6,Patients at least 1 year after prior Eribulin treatment
7,Patients with measurable lesions
8,Patients in whom the major organ functions have been maintained (The criteria listed below are all met within 14 days before enrollment)
Neutrophil count: At least 1,500/mm3
Platelet count: At least 75,000 mm3
Hemoglobin: At least 8.0 g/dL
Total bilirubin: Not exceeding 2.0 mg/dL
AST and ALT: Under 100 IU/L(Under 300 IU/L for patients who has hepatic metastasis)
9,Age of 20-75 years
10,Duration of survival is expected more than 3 months
11,Patients from whom written consent for participation in the study has been obtained in person
Key exclusion criteria
1.Patient with active infection
2.Pregnant, lactating, or intends to become pregnant
3.brain metastasis with clinical symptoms
4.Physician concludes that the patient's participation in this trial is inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Ogata |
Organization
Toho University Omori Medical Center
Division name
Breast and Endocrine Surgery
Zip code
Address
6-11-1, Omori-Nishi Ota-ku, Tokyo , Japan
TEL
0337624151
ogatah@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumi Saito |
Organization
Toho University Omori Medical Center
Division name
Breast and Endocrine Surgery
Zip code
Address
6-11-1, Omori-Nishi Ota-ku, Tokyo , Japan
TEL
0337624151
Homepage URL
fumi.saitou@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 05 | Month | 01 | 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
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | 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
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031130
