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 |
* 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
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
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
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
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
