UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027908 |
|---|---|
| Receipt number | R000031728 |
| Scientific Title | Multicenter retrospective study for brain metastases from breast cancer: Impact of molecular subtype on clinical outcomes |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2023/07/16 10:31:21 |
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Basic information
Public title
Multicenter retrospective study for brain metastases from breast cancer: Impact of molecular subtype on clinical outcomes
Acronym
Multicenter retrospective study for brain metastases from breast cancer
Scientific Title
Multicenter retrospective study for brain metastases from breast cancer: Impact of molecular subtype on clinical outcomes
Scientific Title:Acronym
Multicenter retrospective study for brain metastases from breast cancer
Region
| Japan |
Condition
Condition
brain metastases
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the clinical outcomes (functional preservation, neurological death, and overall survival etc.) base on molecular subtypes of breast cancer in multicenter retrospective study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Loss of functional independence
Neurological death
Key secondary outcomes
Overall survival, tumor control, tumor recurrence, radiation injury, distant recurrence
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
Male and Female
Key inclusion criteria
Breast cancer patients with brain metastases treated by gamma knife surgery are included. Gamma knife surgery was completed until March 31, 2017. The genetic phenotype of breast cancer is mandatory.
Key exclusion criteria
patients with undetermined genetic phenotype
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Higuchi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Neurological Surgery
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-226-2158
yhiguchi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Aoyagi |
Organization
Chiba Cerebral and Cardiovascular Center
Division name
Department of Neurosurgery
Zip code
290-0512
Address
575 Tsurumai, Ichihara city, Chiba, Japan
TEL
0436-88-3111
Homepage URL
kyo-tsuru@nifty.com
Sponsor or person
Institute
Japanese Gamma Knife Society
Institute
Department
Personal name
Funding Source
Organization
ELEKTA RESEARCH FUND
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-226-2158
yhiguchi@faculty.chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JLGK1702
Org. issuing International ID_1
Japanese Gamma Knife Society
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10549-020-05835-8
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10549-020-05835-8
Number of participants that the trial has enrolled
439
Results
The breast cancer subtype was Luminal in 155 patients, Luminal-HER2 in 110, HER2 in 105, and triple negative (TN) in 69. The median overall survival time (months) after GKS was 10.4 in TN, 13.7 in Luminal, 31.4 in HER2 and 35.8 in Luminal-HER2. The cumulative incidence of SD and ND at 5 years after GKS was 69.3% and 9.8%, respectively. HER2-positive patients including HER2 and Luminal-HER2 had lower incidences in SD and ND but higher local recurrence incidence compared to HER2-negative patients.
Results date posted
| 2020 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 01 | Day |
Baseline Characteristics
We included 439 patients treated with GKS at 16 facilities in Japan. Overall survival was analyzed by Kaplan-Meier method. We estimated cumulative incidences of systemic death (SD), neurological death (ND) and local recurrence using competing risk analysis.
Participant flow
We included 439 patients treated with GKS at 16 facilities in Japan. Overall survival was analyzed by Kaplan-Meier method. We estimated cumulative incidences of systemic death (SD), neurological death (ND) and local recurrence using competing risk analysis.
Adverse events
The breast cancer subtype was Luminal in 155 patients, Luminal-HER2 in 110, HER2 in 105, and triple negative (TN) in 69. The median overall survival time (months) after GKS was 10.4 in TN, 13.7 in Luminal, 31.4 in HER2 and 35.8 in Luminal-HER2. The cumulative incidence of SD and ND at 5 years after GKS was 69.3% and 9.8%, respectively. HER2-positive patients including HER2 and Luminal-HER2 had lower incidences in SD and ND but higher local recurrence incidence compared to HER2-negative patients. TN patients required salvage treatment due to distant intracranial metastasis and/or leptomeningeal dissemination. In this study, clinical outcomes including ND, SD and local recurrence differed significantly among subtypes.
Outcome measures
The breast cancer subtype was Luminal in 155 patients, Luminal-HER2 in 110, HER2 in 105, and triple negative (TN) in 69. The median overall survival time (months) after GKS was 10.4 in TN, 13.7 in Luminal, 31.4 in HER2 and 35.8 in Luminal-HER2. The cumulative incidence of SD and ND at 5 years after GKS was 69.3% and 9.8%, respectively. HER2-positive patients including HER2 and Luminal-HER2 had lower incidences in SD and ND but higher local recurrence incidence compared to HER2-negative patients. TN patients required salvage treatment due to distant intracranial metastasis and/or leptomeningeal dissemination. In this study, clinical outcomes including ND, SD and local recurrence differed significantly among subtypes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031728
