UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038296 |
|---|---|
| Receipt number | R000043525 |
| Scientific Title | Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917) |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2020/06/16 09:35:20 |
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Basic information
Public title
Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917)
Acronym
Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917)
Scientific Title
Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917)
Scientific Title:Acronym
Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917)
Region
| Japan |
Condition
Condition
HER2-positive, unresectable and/or metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the real-world efficacy and prognosis of following therapy after standard treatment with anti-HER2 antibodies for patients with HER2-positive unresectable and/or metastatic breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.rwPFS:Real world progression-free survival
2.TTF:Time to treatment failure
3.OS:Overall survival
4.ORR:Objective response rate
5.CBR:Clinical benefit rate
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Women over 20 years old at the start of the following therapy after T-DM1 treatment
2)Has pathologically documented HER2-positive, unresectable or metastatic breast cancer
3)Has received at least one following therapy(Anti-HER2 therapy, other targeted therapy, chemotherapy and/or endocrine therapy) after T-DM1 treatment for HER2-positive unresectable or metastatic breast cancer betweeen Jan 1st, 2014 and Dec 31st, 2018
Key exclusion criteria
1) Has received any investigational new drug or any approved drug without breast cancer indication in any clinical trial as the following therapy after T-DM1 treatment
2) Has declined to participate in this study before the database has been locked
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakayama |
Organization
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Division name
Department of breast and endocrine surgery
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
taqnakayama@hotmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakayama |
Organization
NPO the Supporting Center for Clinical Research and Education
Division name
Kinki Breast Cnacer Study Group-Translational Research
Zip code
565-0871
Address
2-2 Yamadamachi, Suita, Osaka
TEL
06-6897-5037
Homepage URL
taqnakayama@hotmail.com
Sponsor or person
Institute
Kinki Breast Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO.,LTD.
Oncology medical science department
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Prefectural Hospital Organization Osaka International Cancer Institute Certified Review Board
Address
3-1-69, Otemae, Chuo-ku, Osaka
Tel
06-6945-1181
rinri01@opho.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
KBCSG-TR 1917
Org. issuing International ID_1
Kinki Breast Cancer Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院（大阪府）
地方独立行政法人大阪府立病院機構 大阪国際がんセンター（大阪府）
国立病院機構大阪医療センター（大阪府）
国立病院機構北海道がんセンター（北海道）
広島市立病院機構広島市立広島市民病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 15 | 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
128
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
| 2019 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 22 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 29 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
We conduct a retrospective registry study to provide valuable information about the better treatment options in the post T-DM1 settings of HER2-positive unresectable of metastatic breast cancer.
Management information
Registered date
| 2019 | Year | 10 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043525
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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