UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007990 |
|---|---|
| Receipt number | R000009395 |
| Scientific Title | A phase II study of first line chemotherapy by eribulin mesilate for HER2 negative recurrent breast cancer |
| Date of disclosure of the study information | 2012/05/19 |
| Last modified on | 2022/11/28 18:28:43 |
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Basic information
Public title
A phase II study of first line chemotherapy by eribulin mesilate for HER2 negative recurrent breast cancer
Acronym
KBCOG 11
Scientific Title
A phase II study of first line chemotherapy by eribulin mesilate for HER2 negative recurrent breast cancer
Scientific Title:Acronym
KBCOG 11
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 the efficacy and safety of elibulin mesylate for HER2 negative breast cancer not to be treated by chemotherapy after recurrence
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
objective response rate
Key secondary outcomes
progression free survival, over all 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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eliblin mesylate 1.4mg/m2, day1,8, div
Treatment is administered every 3 weeks until evidence of disease progression, unacceptable toxicity, patient refusal.
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)HER2 negative recurrent breast cancer patients
3)with interval period of 4 weeks after post operative adjuvant chemotherapy, 2 weeks after endocrine therapy or radiation
4) with previous treatment by anthracyclin and taxan for perioperative chemotherapy and without chemotherapy after recurrence
5) with evaluable lesion by RECIST criteria
6) ECOG perfomance status 0-2
7) required baseline laboratory parameters (within 2 weeks before registration)
WBC >3,000/mm3
neutrophil >1,500/mm3
Plt >10,000/mm3
Hb >9.0g/dL
AST <2.5 times ULN and ALT <2.5 times ULN (<5.0 with liver metastasis)
serum creatinine <1.5 time ULN
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, liver cirrhosis, psychological disorder treated by antipsychotic drug, ischemic heart disease within 6 months, etc
2) active infection
3) peripheral neuropathy greater than Grade 3
4) male breast cancer
5) pregnant or nursing women, women who like be pregnant
6) with doctors decision for exclusion
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shigeoka |
Organization
Yodogawa Christian Hospital
Division name
Medical Oncology
Zip code
533-0024
Address
1-7-50 Kunijima, Higashi Yodogawa-ku, Osaka
TEL
09072071221
a109137@ych.or.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shigeoka |
Organization
Yodogawa Christian Hospital
Division name
Medical Oncology
Zip code
533-0024
Address
1-7-50 Kunijima, Higashi Yodogawa-ku, Osaka
TEL
09072071221
Homepage URL
y45shigeok@gmail.com
Sponsor or person
Institute
Kobe Breast Cancer Oncology Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Yodogawa Christian Hospital
Address
1-7-50 Kunijima, Higashi Yodogawa-ku, Osaka
Tel
09072071221
a109137@ych.or.jp
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
淀川キリスト教病院(大阪府)、兵庫県立がんセンター(兵庫県)、神戸大学医学部附属病院(兵庫県)、兵庫医科大学病院(兵庫県)、甲南病院(兵庫県)、県立西宮病院(兵庫県)、明和病院(兵庫県)、姫路赤十字病院(兵庫県)、大山病院(兵庫県)、尼崎総合医療センター(兵庫県)、赤穂市民病院(兵庫県)、済生会兵庫県病院(兵庫県)、神鋼記念病院(兵庫県)、製鉄記念広畑病院(兵庫県)、加古川医療センター(兵庫県)、西神戸医療センター(兵庫県)、神戸医療センター(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 04 | Month | 24 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 19 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009395
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| Registered date | File name |
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| Registered date | File name |
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