UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014189 |
|---|---|
| Receipt number | R000016319 |
| Scientific Title | Reinduction with lapatinib followed by retreatment with trastuzumab-based therapy after disease progression multi-HER2 targeted therapies in HER2-positive metastatic breast cancer |
| Date of disclosure of the study information | 2014/06/06 |
| Last modified on | 2020/06/07 10:32:03 |
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Basic information
Public title
Reinduction with lapatinib followed by retreatment with trastuzumab-based therapy after disease progression multi-HER2 targeted therapies in HER2-positive metastatic breast cancer
Acronym
Recover HER2
Scientific Title
Reinduction with lapatinib followed by retreatment with trastuzumab-based therapy after disease progression multi-HER2 targeted therapies in HER2-positive metastatic breast cancer
Scientific Title:Acronym
Recover HER2
Region
| Japan |
Condition
Condition
HER2-positive metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
CBR
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CBR
Key secondary outcomes
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
lapatinib
trastuzumab
chemothrapies
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 breast cancer
2) >20 y
3) PS 0-2
4)metastatic or advanced breast cancer
5)HER2 positve
Key exclusion criteria
1) active synchuronous cancer
2) active infectious disease
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ito |
Organization
JFCR
Division name
Breast Med Oncol
Zip code
135-8550
Address
3-8-31 ariake koto toyo
TEL
03-3520-0111
yito@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Yago |
Organization
JFCR
Division name
Breast Med Oncol
Zip code
135-8550
Address
3-8-31 ariake koto toyo
TEL
03-3520-0111
Homepage URL
michiko.yago@jfcr.or.jp
Sponsor or person
Institute
JFCR Breast Med Oncol
Institute
Department
Personal name
Funding Source
Organization
JFCR Breast Med Oncol
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
JFCR-CIH
Address
3-8-31 ariake koto toyo
Tel
03-3520-0111
michiko.yago@jfcr.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 06 | 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
0
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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016319
