UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007948 |
|---|---|
| Receipt number | 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 12:43:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shsasada@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008919
