UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012210 |
|---|---|
| Receipt number | R000014276 |
| Scientific Title | Observational study for treatment outcome in patients with HER2-positive metastatic breast cancer who received pertuzumab combination chemotherapy. |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2020/05/10 12:19:12 |
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Basic information
Public title
Observational study for treatment outcome in patients with HER2-positive metastatic breast cancer who received pertuzumab combination chemotherapy.
Acronym
Observational study for treatment outcome in patients with HER2-positive metastatic breast cancer who received pertuzumab combination chemotherapy.
Scientific Title
Observational study for treatment outcome in patients with HER2-positive metastatic breast cancer who received pertuzumab combination chemotherapy.
Scientific Title:Acronym
Observational study for treatment outcome in patients with HER2-positive metastatic breast cancer who received pertuzumab combination chemotherapy.
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 efficacy and safety from clinical outcome in patients with HER2-positive metastatic breast cancer who received pertuzumab combination chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Response rate
Progression-free survival
Overall survival
Time to treatment failure
The incidence of the adverse event (such as infusion reaction and decreasing of LVEF)
Treatment line
Treatment regimen
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 confirmed breast cancer.
2) HER2-positive(3+ staining by IHC or HER2 gene amplification by FISH) metastatic breast cancer.
3) Received pertuzumab combination chemotherapy after September 12, 2013.
4) Written informed consent to participate.
Key exclusion criteria
1) Physician judged improper to entry this trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Miwa |
Organization
Kurume University Hospital
Division name
Cancer Multidisciplinary Treatment Center
Zip code
830-0011
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-35-3311
miwakeisuke@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Miwa |
Organization
Kurume University Hospital
Division name
Cancer Multidisciplinary Treatment Center
Zip code
830-0011
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-35-3311
Homepage URL
miwakeisuke@gmail.com
Sponsor or person
Institute
Kurume University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurume 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
The Ethical Committee of Kurume University
Address
67 Asahi-machi, Kurume city, Fukuoka
Tel
0942-31-7917
sangaku@kurume-u.ac.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
久留米大学病院(福岡県)、社会保険久留米第一病院(福岡県)、国立病院機構九州医療センター(福岡県)、公立八女総合病院企業団(福岡県)、大牟田市立総合病院(福岡県)、聖マリア病院(福岡県)、大分県済生会日田病院(大分県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | 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
10
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
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this observational study is to investigate the efficacy and safety of pertuzumab combination chemotherapy in patients with HER2-positive metastatic breast cancer by using collected practical data.
Management information
Registered date
| 2013 | Year | 11 | Month | 04 | Day |
Last modified on
| 2020 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014276
