UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008802 |
|---|---|
| Receipt number | R000010284 |
| Scientific Title | Safety trial of eriburin treatment to patient who has peripheral neuropathy |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2019/02/28 13:43:35 |
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Basic information
Public title
Safety trial of eriburin treatment to patient who has peripheral neuropathy
Acronym
H(Hiroshima)-STEP
Scientific Title
Safety trial of eriburin treatment to patient who has peripheral neuropathy
Scientific Title:Acronym
H(Hiroshima)-STEP
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety of Eribulin in breast cancer patients with peropheral neuropathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence rates of peripheral neuropathy G3(CTCAE)
Key secondary outcomes
Response Rate
Overall Survival
FACT-NTX EQ-5D
Safety
PNQ
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
1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Histologically or cytologically confirmed breast cancer.
2) Unresectable metastatic breast cancer.
3)Previously treated with chemotherapeutic regimens including an anthracycline and a taxane first-line chemotherapy
4)Having evaluable disease according to RECIST
5)Prior chemotherapy 0-2 regimens for unresectable metastatic status
6)Having an adequate interval from prior therapy
1.chemotherapy:21days
2.endocrine therapy:7days
3.radiation therapy:14days
4.major surgery:28days
5.minor surgery:14days
6)PS (ECOG) 0-2
7)Eligible patient for eribulin therapy
8)Peripheral neuropathy G1 or G0(experienced peripheral neuropathy caused from previous chemotherapy)
9)Adequate organ functions
1.neutrophil=>1000mm3
2.platelet count=>75000mm3
3.AST,ALT=<2.5 times ULN(<5.0 with liver metastasis)
4.total bilirubin=<1.5 times ULN
serum creatinine=<1.5mg/dL
10)Female over 20 years old
11)Obtained written informed consent
Key exclusion criteria
1)Forbidden case to use eribulin
2)Serious bone marrow suppression
3)Allergy to component of eribulin
4)Pregnant or like be pregnant
5)Serious liver or renal disorder
6)Inadequate interval from prior therapy
7)Symptomatic brain metastasis
8)Patient with CNS disease, DM, RA, or bone metastasis (possible involvement peripheral neropathy)
9)Peripheral neuropathy caused from surgery
10)With doctors decision for exclusion
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morihito Okada |
Organization
Hiroshima Unversity Hospital
Division name
Department of surgical oncology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5869
morihito1217@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Shigematsu |
Organization
Hiroshima Unversity Hospital
Division name
Department of surgical oncology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5869
Homepage URL
shsasada@hiroshima-u.ac.jp
Sponsor or person
Institute
Dept of surgical oncology, Hiroshima university hospital
Institute
Department
Personal name
Funding Source
Organization
Dept of surgical oncology, Hiroshima university hospital
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
| 2012 | Year | 09 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2019 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010284
