UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047290 |
|---|---|
| Receipt number | R000053932 |
| Scientific Title | Pooled-analysis of prospective observational studies evaluated the efficacy and safety of bevacizumab(BEV) and paclitaxel(PTX) as the first-line chemotherapy for HER2-negative metastatic breast cancer(MBC). |
| Date of disclosure of the study information | 2022/03/26 |
| Last modified on | 2022/03/26 14:20:20 |
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Basic information
Public title
Pooled-analysis of prospective observational studies evaluated the efficacy and safety of bevacizumab(BEV) and paclitaxel(PTX) as the first-line chemotherapy for HER2-negative metastatic breast cancer(MBC).
Acronym
Pooled analysis of prospective bevacizumab observational studies for metastatic breast cancer
Scientific Title
Pooled-analysis of prospective observational studies evaluated the efficacy and safety of bevacizumab(BEV) and paclitaxel(PTX) as the first-line chemotherapy for HER2-negative metastatic breast cancer(MBC).
Scientific Title:Acronym
Pooled analysis of prospective bevacizumab observational studies for metastatic breast cancer
Region
| Japan | Europe |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To generate the large scale real-world data which has more accurate efficacy and safety of BEV+PTX as the first-line chemotherapy for HER2 negative MBC by pooling real world data including B-SHARE.
To enhance the credibility of data in small subgroups (ex. Triple negative breast cancer etc.)
To validate the prognostic index developed in the ATHENA trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival
Objective response rate
Time to treatment failure
OS and PFS stratified by the prognostic factor index
safety
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
Key inclusion criteria in each study (B-SHARE,ML21165,AVAREG,AVANTI)
Key exclusion criteria
Key exclusion criteria in each study (B-SHARE,ML21165,AVAREG,AVANTI)
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Yamamoto |
Organization
Kumamoto University
Division name
Department of Breast and Endocrine Surgery
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL
096-373-66--5521
yyamamoto@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiro |
| Middle name | |
| Last name | Soma |
Organization
Japan Breast Cancer Research Group
Division name
Management Department
Zip code
103-0016
Address
9-4-3F, Nihonbashikoamichou, Cyuouku, Tokyo, Japan
TEL
03-6264-8873
Homepage URL
https://jbcrg.jp/clinicaltrials/679/
souma@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Faculty of Life Sciences, Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
Tel
096-373-5657
ski-shien@jimu.kumamoto-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
https://jbcrg.jp/clinicaltrials/679/
Publication of results
Partially published
Result
URL related to results and publications
https://jbcrg.jp/clinicaltrials/679/
Number of participants that the trial has enrolled
2474
Results
The median OS was 21.4 M
7 independent prognostic factors for OS were identified (tumor subtype, age, ECOG PS, DFI, liver metastasis, number of metastatic organs, prior anthracycline or taxane treatment).
Results date posted
| 2022 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age 59 years old.
ECOG performance status 2 or above was 201 (8.3%).
Participant flow
From the four prospective observational studies, 2902 patients were included in dataset for this pooled analysis. Among them, 2474 HER2-negative metastatic breast cancer patients were used in this pooled analysis, excluding patients not receiving bevacizumab plus paclitaxel as first-line chemotherapy (n=279), locally advanced or local recurrent breast cancer without distant metastasis (n=184), and patients with other reason for ineligibility (n=13)
Adverse events
Hypertension 25.2%, Hemorrhage 19.5%, Proteinuria 18.6%, Neutropenia 17.0%, Peripheral neuropathy 14.1%, Thromboembolism 1.6%, Gastrointestinal perforation 0.2%, Cardiac failure 0.2%
Outcome measures
The median OS was 21.4, 95% confidence interval 19.8 to 22.7M.
The seven independent prognostic factors (tumor subtype, age, Eastern Cooperative Oncology Group [ECOG] performance status [PS], disease-free interval [DFI], liver metastases, number of metastatic organs, and prior anthracycline or taxane treatment) for OS found in this analysis included five risk factors (RFs; DFI <24 M, ECOG PS 2, and/or >3 metastatic organ sites, triple-negative breast cancer, and prior anthracycline and/or taxane therapy). High- (>3 RFs; median OS: 12.6 M) and intermediate-risk groups (2 RFs; median OS: 18.0 M) had significantly worse prognosis than the low-risk group (<1 RF; median OS: 27.4 M; P<0.0001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pooled analysis of 4 prospective observational studies
Management information
Registered date
| 2022 | Year | 03 | Month | 26 | Day |
Last modified on
| 2022 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053932
