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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012210
Receipt No. 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

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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
Email 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
Email miwakeisuke@gmail.com

Sponsor
Institute Kurume University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014276

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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