UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010466
Receipt number R000012220
Scientific Title Phase II study of Bevacizumab in combination with Paclitaxel in metastatic breast cancer patients with asymptomatic brain metastases.
Date of disclosure of the study information 2013/04/10
Last modified on 2013/04/09 18:02:54

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Basic information

Public title

Phase II study of Bevacizumab in combination with Paclitaxel in metastatic breast cancer patients with asymptomatic brain metastases.

Acronym

Phase II study of Bevacizumab in combination with Paclitaxel in metastatic breast cancer patients with asymptomatic brain metastases.

Scientific Title

Phase II study of Bevacizumab in combination with Paclitaxel in metastatic breast cancer patients with asymptomatic brain metastases.

Scientific Title:Acronym

Phase II study of Bevacizumab in combination with Paclitaxel in metastatic breast cancer patients with asymptomatic brain metastases.

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of bevacizumab in combination with Paclitaxel in advanced Breast cancer patients with asymptomatic brain metastases.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Response Rate for intracranial metastases

Key secondary outcomes

Safety, Overall Response Rate(ORR), Disease Control Rate(DCR), Progression Free Survival(PFS)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

bevacizumab 10mg/kg, day 1, 15
paclitaxel 90mg/mm2, day 1, 8, 15
Treatment is administered every 4 weeks until evidence of disease progression, unacceptable toxicity, patient refusal.

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 confirmed breast cancer
2) Age20=<
3) ECOG performance status of 0 to 2
4) With one or more measurable brain metastasis based on RECIST(1cm=<)
5) No prior Bevacizumab or Paclitaxel
6) Adequate organ function, evaluated within 28 days before enrollment as
WBC>=3,000/mm3
Neu>=1,500/mm3
Plt>=75,000/mm3
hemoglobin >=9.0g/dL
AST,ALT=<2.5xULN
Cr=<ULN
Proteinuria<1+
7) All patients provided written informed consent

Key exclusion criteria

1) Symptomatic brain metastasis
2) Active double cancer
3) Scheduled operation
4) Patients with a history of severe hypersensitivity to drugs used in this trial
5) Uncontrolable hypertension
6) Currently have or have a history of a Ascites ,Pleural effusion or pericardial effusion which requires treatment
7) Problematic infection
8) Uncontrolable complications
9) Sever complications
10) Pregnant or lactation women, or women with known or suspected pregnancy
11) Decision of ineligibility by a physician

Target sample size

23


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yu Tsubota

Organization

Kansai medical University

Division name

Surgical department

Zip code


Address

2-3-1 Shin-machi, Hirakata-shi, Osaka 573-1191 JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kansai medical university

Division name

Surgical department

Zip code


Address

2-3-1 Shin-machi, Hirakata-shi, Osaka 573-1191 JAPAN

TEL


Homepage URL


Email



Sponsor or person

Institute

Kansai medical university

Institute

Department

Personal name



Funding Source

Organization

None

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


Address


Tel


Email



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

2013 Year 04 Month 10 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

Open public recruiting

Date of protocol fixation

2013 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 04 Month 10 Day

Last modified on

2013 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012220


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name