UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009568 |
|---|---|
| Receipt number | R000011227 |
| Scientific Title | A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressing |
| Date of disclosure of the study information | 2012/12/21 |
| Last modified on | 2017/06/10 18:47:23 |
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Basic information
Public title
A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressing
Acronym
OMC-BC03
Scientific Title
A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressing
Scientific Title:Acronym
OMC-BC03
Region
| Japan |
Condition
Condition
Advanced or metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy and safety of Eribulin are evaluating as the first or secondary chemotherapy for advanced or metastatic breast cancer patient without HER2 overexpressing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective Response Rate
Key secondary outcomes
Duration of Response, Progression free survival, Overall survival, Safety, QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
December 1, 2012 to December 31, 2015
Eriburin mesylate 1.4mg/m2, Days 1, 8 q21 days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. histlogically or cytologically confirmed breast cancer
2. advanced or metastatic breast cancer patient without HER2 overexpressing
3. with interval period of 4 weeks after pot operative adjuvant chemotherapy, 2 weeks after endocrine therapy or radiation
4. with previous treatment by anthracyclin and taxan for peroperative chemotherapy, and without chemotherapy or only one chemotherapy after advanced or metastasis(However, a history of treatment does not matter about some cases that the use of these drugs are not suitable for due to allergies, comorbidity, and other reasons.).
5. with evaluable lesion by RECIST criteria
6. ECOG performance status 0-2
7. required baseline laboratory parameters (within 1 weeks before registration) WBC > 3,000/mm3, neutophil > 1,500/mm3, Plt > 100,000/mm3, Hb > 9.0 g/dL, AST < 2.0 times ULN adn ALT < 2.0 times ULN, serum creatinine < 1.5 times ULN, normal cardiac function
8. with life expectancy greater than 3 months
9. written informed consent was obtained
Key exclusion criteria
1. serious complication or past history:
with symptomatic heart failure,
ischemic heart disease within 6 months,
liver cirrhosis,
psychological disorder treated by antipsychotic drug,
uncontrolable diabetes, etc
2. active infection
3. The anamnesis of the hypersensitivity to Eribulin
4. peripheral neuropathy greater than Grade 3
5. male breast cancer
6. under pregnancy or breast-feeding, and possibility (will) of pregnancy.
7. with doctors decision for exclusion
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Iwamoto |
Organization
Osaka Medical College
Division name
General and Gastroenterological Surgery
Zip code
Address
2-7 Daigakumachi, Takatsuki City, Osaka, Japan
TEL
072-683-1221
sur121@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Iwamoto |
Organization
Osaka Medical College
Division name
General and Gastroenterological Surgery
Zip code
Address
2-7 Daigakumachi, Takatsuki City, Osaka, Japan
TEL
072-683-1221
Homepage URL
sur121@poh.osaka-med.ac.jp
Sponsor or person
Institute
General and Gastroenterological Surgery, Osaka Medical College
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
| 2012 | Year | 12 | Month | 21 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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 | 12 | Month | 17 | Day |
Last modified on
| 2017 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011227
| 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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