UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008955 |
|---|---|
| Receipt number | R000010476 |
| Scientific Title | 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 | 2012/09/24 |
| Last modified on | 2019/05/17 16:00:32 |
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Basic information
Public title
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
Scientific Title
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
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 evaluate efficacy and safety of 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
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Progression free survival between randomization and first progression
Key secondary outcomes
Progression free survival between randomization and second progression
Progression free survival between first registration and first progression
Progression free survival between first registration and second progression
Response rate of induction treatment
Response rate of second treatment
Overall survival since randomization
Overall survival since first registration
Safety
Health Related QOL
The related study defines as below in the another protocol
Feasibility of biopsy
Alteration of immunohistochemistry between primary and metastatic tumor
Exploratory immunohistochemistry
Whole exon sequencing of genome
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After 6 cycles of induction treatment with paclitaxel plus bevacizumab, continue maintenance treatment with paclitaxel plus bevacizumab until disease progression, then perform endocrine treatment until disease progression
Interventions/Control_2
After 6 cycles of induction treatment with paclitaxel plus bevacizumab, perform maintenance treatment with endocrine agent until disease progression, then resume treatment with paclitaxel plus bevacizumab until disease progression
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
1)Pathological or cytological confirmed breast cancer
2)Postmenopausal inoperable breast cancer with metastatic disease or recurrence
3)HER2 negative(IHC 0, 1, 2 or ISH<2.0)
4)Performance Status 0-2
5)Evaluable lesion by RECIST(eligible in case with bone metastasis alone or carcinomatous fluid retention)
6)Recurrence during adjuvant endocrine treatment, or within 6 months after finishing of adjuvant endocrine treatment. Disease progression on endocrine treatment for inoperable or recurrence.
Recurrence during adjuvant endocrine treatment, or within 6 months after finishing of adjuvant endocrine treatment Disease progression on endocrine treatment for inoperable or recurrence. Not adopt this criteria in multiple organs (lung or liver) metastasis
7)None or 1 regimen of prior chemotherapy for metastatic breast cancer
8)No influence of prior treatment
9)Maintained organ function
10)More than 3months life expectancy
11)Written informed consent
Key exclusion criteria
1)Prior treatment of bevacizumab
2)Allergy to paclitaxel
3)Brain metastasis with risk of bleeding
4)Pregnancy, nursing
5)Active hepatitis
6)Non-healing severe wound or traumatic bone fracture
7)Pleural effusion, ascites or pericardial effusion that requires drainage
8)Uncontrollable hypertension
9)Usage of antithrombotic agents
10)Continuous administration of corticosteroid
11)Symptomatic congestive heart failure, unstable angina, arrhythmia requiring treatment, myocardial infarction within 1 year
12)Idiopathic pulmonary fibrosis or interstitial pneumonitis
13)Symptomatic cerebral vascular disturbance, or its history within 1 year
14)Deep venous thrombosis or pulmonary infarction, or its history within 1 year
15)Perforation of digestive tract, or its history within 1 year
16)Plan of surgery with risk of bleeding
Double cancer within 5 years of disease free interval
17)Symptomatic dysfunctional peripheral neuropathy
18)Active peptic ulcer
19)Body temperature more than 38C
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 | 09 | Month | 24 | 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 | 06 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | 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
Management information
Registered date
| 2012 | Year | 09 | Month | 21 | 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=R000010476
