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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007948
Receipt No. R000008919
Scientific Title Breast Cancer Study of Clinical Efficacy and Safty of Avastin with Paclitaxel in the 1st-taxane-line
Date of disclosure of the study information 2012/05/14
Last modified on 2020/03/13

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Basic information
Public title Breast Cancer Study of Clinical Efficacy and Safty of Avastin with Paclitaxel in the 1st-taxane-line
Acronym BRAVE study
Scientific Title Breast Cancer Study of Clinical Efficacy and Safty of Avastin with Paclitaxel in the 1st-taxane-line
Scientific Title:Acronym BRAVE study
Region
Japan

Condition
Condition HER2-negative metastatic breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the efficacy and safety of weekly paclitaxel + bevacizumab in patients with HER2-negative taxane-untreated metastatic breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes Safety, Progression free survival , Overall survival, Time to treatment failure, Disease control rate, QOL

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 All patients received paclitaxel 90 mg/m2 iv on days 1, 8, and 15 and bevacizumab 10 mg/kg iv on days 1 and 15 in cycles every 28 days.
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

Not applicable
Gender Female
Key inclusion criteria (1) Histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer.
(2) Unresectable metastatic breast cancer.
(3) With measurable lesions.
(4) Female over 20 years old.
(5) ECOG PS 0-2.
(6) HER2 negative.
(7) Taxane-untreated metastatic breast cancer.(Patients who had received taxane-based adjuvant therapy were required to have had a disease-free interval of at least 12 months after completion of taxane therapy.)
(8) Sufficient organ function. (Ex. Meeting following criteria.)
1. Neutrophil >=1,500 mm3
2. Platelet >=100,000 mm3
3. AST,ALT <=2.5 x upper limit of normal (ULN) (<=5 x upper limit of normal (ULN) in case of liver metastasis)
4. Serum total bilirubin <=1.5 mg/dL
5. Serum creatinine <=1.5 mg/dL
6. Urine protein <=1+
(9) Signed written informed consent.
Key exclusion criteria (1) Forbidden case to use paclitaxel and bevacizumab.
(2) With uncontrollable hypertension.
(3) Nonhealing wound.
(4) With VTE or PE.
(5) With GI perforation or Digestive ulcer.
(6) Severe cardiac disease (Ex. Congestive heart failure or coronary artery disease)
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Morihito
Middle name
Last name Okada
Organization Hiroshima Unversity Hospital
Division name Department of Surgical Oncology
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-8569
Email morihito@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Shinsuke
Middle name
Last name Sasada
Organization Hiroshima Unversity Hospital
Division name Breast Surgery
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-8569
Homepage URL
Email shsasada@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima University
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 Center for Integrated Medical Research, Hiroshima University
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
Tel 082-257-1752
Email protocol@cimr.hiroshima-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
2012 Year 05 Month 14 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 Completed
Date of protocol fixation
2012 Year 05 Month 10 Day
Date of IRB
2012 Year 05 Month 10 Day
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2017 Year 02 Month 28 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 05 Month 14 Day
Last modified on
2020 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008919

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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