UMIN-CTR Clinical Trial

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010476