UMIN-CTR Clinical Trial

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