UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009978 |
|---|---|
| Receipt number | R000011691 |
| Scientific Title | Pilot Study: Paclitaxel plus Bevacizumab followed by FEC100 in HER2-negative locally (stage IIIB/IIIC) advanced breast cancer. |
| Date of disclosure of the study information | 2013/02/06 |
| Last modified on | 2017/02/09 09:06:18 |
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Basic information
Public title
Pilot Study: Paclitaxel plus Bevacizumab followed by FEC100 in HER2-negative locally (stage IIIB/IIIC) advanced breast cancer.
Acronym
Paclitaxel plus Bevacizumab followed by FEC100 in HER2-negative locally advanced breast cancer. (KBOG-1201)
Scientific Title
Pilot Study: Paclitaxel plus Bevacizumab followed by FEC100 in HER2-negative locally (stage IIIB/IIIC) advanced breast cancer.
Scientific Title:Acronym
Paclitaxel plus Bevacizumab followed by FEC100 in HER2-negative locally advanced breast cancer. (KBOG-1201)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy of Paclitaxel plus Bevacizumab followed by FEC100 in HER2-negative locally (stage IIIB/IIIC) advanced 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
non residual tumor classification rate
pathological complete response rate
safety
progression-free survival
3years survival rate
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
Administrate 4 cycles of combination with Paclitaxe and Bevacizumab follwed by 4 cycles of FEC100. Operation is performed after chemotherapy.
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.Unresectable locally advanced(stage IIIB/IIIC) breast cancer
2.HER2 negative confirmed by IHC or FISH
3.Previously untreated with chemotherapy, radiationtherapy, endocrinetherapy and immunotherapy for locally advanced breast cancer
4.N3 confirmed by histological diagnosis or cytodiagnosis
5.ECOG performance status 0-1
6.Having at least one measureable lesion
Key exclusion criteria
1) Patient with a history of the past of the breast cancer
2) Ineligible based on decision of an investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Niikura |
Organization
Tokai University School of Medicine
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa, Japan 259-1193
TEL
0463-93-1121
niikura@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Niikura |
Organization
Tokai University School of Medicine
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
143 SHimokasuya Isehara 259-1193
TEL
0463-93-1121
Homepage URL
niikura@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
NPO Kanagawa Breast Oncology Group(KBOG)
Institute
Department
Personal name
Funding Source
Organization
NPO Kanagawa Breast Oncology Group(KBOG)
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
東海大学付属病院
聖マリアンナ医科大学病院
北里大学病院
横浜市立大学附属市民総合医療センター
横浜市立大学附属病院
神奈川県立がんセンター
聖マリアンナ医科大学附属研究所ブレスト＆イメージング先端医療センター付属クリニック
大船中央病院
横浜労災病院
湘南記念病院
みなと赤十字病院
横浜旭中央病院
東海大学付属八王子病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 06 | 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 | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 06 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011691
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