UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008140 |
|---|---|
| Receipt number | R000009588 |
| Scientific Title | A phase II study of Paclitaxel combined with Bevacizumab in HER2 negative metastatic Breast Cancer |
| Date of disclosure of the study information | 2012/06/12 |
| Last modified on | 2021/12/19 22:02:44 |
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Basic information
Public title
A phase II study of Paclitaxel combined with Bevacizumab in HER2 negative metastatic Breast Cancer
Acronym
KBCOG 12
Scientific Title
A phase II study of Paclitaxel combined with Bevacizumab in HER2 negative metastatic Breast Cancer
Scientific Title:Acronym
KBCOG 12
Region
| Japan |
Condition
Condition
metastatic Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of paclitaxel in combination with bevacizumab in metastatic breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate
Key secondary outcomes
Clinical benefit rate, Progression-free survival, Safety
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
paclitaxel 90mg/mm2, day 1, 8, 15
bevacizumab 10mg/kg, day 1, 15
Treatment is administered every 4 weeks until evidence of 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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically confirmed primary breast cancer
2) Age>=20, <=80
3) ECOG PS: 0-1
4) Measurable lesion
5) Primary chemotherapy refractory
6) Without the symptomatic brain metastasis
7) Without paclitaxel for previous treatment
(Eligible if paclitaxel are used in neo-adjuvant or adjuvant setting and completed more than 12 month before registration)
8) Required baseline laboratory parameters before registers:
WBC : >= 3,000mm3 or neutrophil : >= 1,500mm3
Plt : >= 75,000mm3
Hb : >= 9.0g/dl
AST <= 2.5 times ULN and ALT <= 2.5 times ULN (<=5.0 with liver metastasis)
Serum creatinine <= ULN
Normal EOG
9) Signed informed consent of the patient for the registration
Key exclusion criteria
1) Previously treated with bevacizumab
2) Primary chemotherapy refractory with Paclitaxel
3) The operation has been scheduled for the examination period
4) Uncontrollable hypertension
5) Symptomatic brain metastasis
6) Anaphylaxis against drugs used in protocol treatment
7) Uncontrollable ascites, pleural effusion
8) Active infection, Severe complications (abnormal electrocardiogram, heart failure, arrhythmia, thromboembolism, etc)
9) Severe infection or serious complications, such as hypoalimentation
10) Other active malignancies
11) Pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant
12) Doctors decision for exclusion
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Meiwa Hospital
Division name
Department of breast and endocrine surgery
Zip code
6638186
Address
Kaminaruo-cho 4-31, Nishinomiya, Hyogo, 663-8186
TEL
0798-47-1767
mm-kishi@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Meiwa Hospital
Division name
Department of breast and endocrine surgery
Zip code
6638186
Address
Kaminaruo-cho 4-31, Nishinomiya, Hyogo, 663-8186
TEL
0798-47-1767
Homepage URL
mm-kishi@hotmail.co.jp
Sponsor or person
Institute
Kobe Breast Cancer Oncology Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Meiwa Hospital
Address
Nishinomiya city, Agenaruocho, 4-31
Tel
0795
mm-kishi@hotmail.co.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 | 06 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009588
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
