UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009300 |
|---|---|
| Receipt number | R000010920 |
| Scientific Title | Exploratory research of predictive factors in randomized phase 2 study comparing maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab. |
| Date of disclosure of the study information | 2012/11/12 |
| Last modified on | 2019/05/17 16:02:47 |
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Basic information
Public title
Exploratory research of predictive factors in randomized phase 2 study comparing maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab.
Acronym
CAPTURE-TR
Scientific Title
Exploratory research of predictive factors in randomized phase 2 study comparing maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab.
Scientific Title:Acronym
CAPTURE-TR
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To propose a model of subgroup classification based on factors to predict anti-tumor efficacy and tolerance in the maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab.
Basic objectives2
Others
Basic objectives -Others
translational research
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis og intratumor genomic sequencing, intratumor genomic expression, intratumor protein expression and prepheral blood protein concentration
Key secondary outcomes
Analysis of relationship to clinical information
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Obtained informed consent of CAPTURE trial
Key exclusion criteria
none
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ito |
Organization
Cancer Institute Hospital , Japanese Foundation for Cancer Research
Division name
Breast Medical Oncology, Breast Oncology Center
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
yito@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Yago |
Organization
Secretariat of CAPTURE Clinical Trial
Division name
Registration Center
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
Homepage URL
michiko.yago@jfcr.or.jp
Sponsor or person
Institute
CAPTURE Clinical Trial Group
Institute
Department
Personal name
Funding Source
Organization
Breast Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research
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
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Address
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
Tel
03-3520-0111
med.shinsa@jfcr.or.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
| 2012 | Year | 11 | Month | 12 | 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
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
| 2012 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tumor tissue
1) 25 slides of paraffin embed primary tumor and frozen tumor samples when available.
2) Frozen tumor samples and 25 slides of paraffin embed metastatic tumor of which informed consent was obtained.
Peripheral blood
1) Pre-sampling and post 4, 12 weeks of CAPTURE treatment. Immediately after PD.
2) 20 ml of blood drawing at pre-treatment
3) 16 ml of blood drawing at post 4, 12 weeks of treatment or immediately after PD
Methods
1) Intratumor genomic sequencing, Whole exon sequencing by next-generation sequencer HiSeq 2000
2) Intratumor genomic expression, GeneChip,quantative RT-PCR
3) Intratumor protein analysis, immunohistochmistry
ER,PgR,HER2,Ki67,VEGF-A,VEGF-R2,SDF-1,twist,snail,slug,E-cadherin,Vimentin,ALDH1,Nucleostemin,CD133,CD44,CD24,DLL4,p-mTOR,p-Akt,p-S6,p53 etc.
4) Peripheral blood concentration, ELISA
VEGF-A,SDF-1,b-FGF,sVEGF-R2,PTX3,thrombomodulin,ICAM-1,VCAM-1,E-selectin etc.
Management information
Registered date
| 2012 | Year | 11 | Month | 09 | Day |
Last modified on
| 2019 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010920
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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