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

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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 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

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

Value
https://center6.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