UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010334 |
|---|---|
| Receipt number | R000012097 |
| Scientific Title | A phase II trial of early phase eribulin for metastatic breast cancer. |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2024/03/21 11:15:27 |
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Basic information
Public title
A phase II trial of early phase eribulin for metastatic breast cancer.
Acronym
KOEB
Scientific Title
A phase II trial of early phase eribulin for metastatic breast cancer.
Scientific Title:Acronym
KOEB
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of early phase eribulin for locally advanced and metastatic breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
objective response rate
Key secondary outcomes
progression free survival, overall survival, safety
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
administration of eribulin 1.4mg/m2 on day1 and day8 every 3 weeks
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)Histologically or cytologically confirmed breast cancer.
2)ECOG performance status 0-2
3)Measurable disease
4)Three or less regimens of chemotherapy for breast cancer and one or less regimen of chemotherapy for locally advanced or metastatic breast cancer
5)No history of eribulin treatment
6) Meet the cirteria of baseline labolatory parameters as below.
Netrophils count 1500/mm3 or more, Plt 100,000/mm3 or more, Hb 9g/dl or more, T.Bil 2mg/dl or less, GOT and GPT within 2.5ULN, CRN 1.5mg/dL or less,
7)Expected to have more than 3 months of survival
8)Normal ECG
9)Written informed consent
Key exclusion criteria
1)Patients with infection or fever
2)History of severe allergy
3)History of renal or liver failure
4)Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray
5)Patients with pleural effusion of ascites that needs to be treated
6)Patients with hypertention or diabetes that are not controlled by medication
7)Administration of systemic steroids
8)Pregnancy
9)Patients who had transfusion or injection of G-CSF within 7 days before the treatment
10)Other active malignancies
11)Clinically significant mental disorder
12)CNS involvement
13)Participants of other treatment protocol
14)Other medical conditions that could limit a patient's ability to undertake study therapy
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of surgery
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-3353-1211
mmk_csaito@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chisato Saito |
Organization
Keio University School of Medicine
Division name
Department of surgery
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo Japan
TEL
03-3353-1211
Homepage URL
mmk_csaito@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine Department of surgery breast group
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
東京医療センター(東京都)、足利赤十字病院(栃木県)、水戸赤十字病院（茨城県）、那須赤十字病院（栃木県）、済生会宇都宮病院（栃木県）、公立福生病院（東京都）、共済組合立川病院（東京都）、北里研究所病院（東京都）、けいゆう病院（神奈川県）、平塚市民病院（神奈川県）、大和市立病院（神奈川県）、済生会神奈川病院（神奈川県）、済生会横浜市東部病院（神奈川県）、さいたま市立病院（埼玉県）、埼玉社会保険病院（埼玉県）、東京歯科大学市川病院（千葉県）、佐野厚生病院（栃木県）、川崎市立川崎病院（神奈川県）、川崎市立井田病院（神奈川県）、日野市立病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
| 2013 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012097
