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Recruitment status Terminated
Unique ID issued by UMIN UMIN000009300
Receipt No. 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

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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
Last 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
Email yito@jfcr.or.jp

Public contact
1st 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
Email michiko.yago@jfcr.or.jp

Sponsor
Institute CAPTURE Clinical Trial Group
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010920

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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