UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007445 |
|---|---|
| Receipt number | R000008776 |
| Scientific Title | Feasibility study of weekly paclitaxel plus gemcitabine for metastatic and recurrent breast cancer with negative HER2 |
| Date of disclosure of the study information | 2012/03/06 |
| Last modified on | 2016/12/12 14:31:12 |
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Basic information
Public title
Feasibility study of weekly paclitaxel plus gemcitabine for metastatic and recurrent breast cancer with negative HER2
Acronym
KBC-SG1104
Scientific Title
Feasibility study of weekly paclitaxel plus gemcitabine for metastatic and recurrent breast cancer with negative HER2
Scientific Title:Acronym
KBC-SG1104
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
It is conceivable that the effect and duration of response can be improved when gemcitabine is added to the weekly paclitaxel regimen for patients with advanced breast cancer. The purpose of this study is, therefore, to evaluate safety and effectiveness of combination therapy of weekly paclitaxel and gemcitabine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate, safety
Key secondary outcomes
response duration, time to progression, overall survival
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 80mg/m2 day1,8
gemcitabine 1250mg/m2 day1,8
every 21 days, 6 cycles
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.Inoperable or recurrent breast cancer
2.HER2 negative breast cancer
3.Women aged 20 or over
4.ECOG Performance status: 0-1
5.Having measurable lesions
6.Off-therapy period prior to the study:
Chemotherapy,radiation therapy >= 4 weeks
Endocrine therapy >= 2 weeks
7.sufficient organ function
8.Written informed consent
Key exclusion criteria
1.Allergy to clemohol EL
2.Significant interstitial pneumonia or pulmonary fibrosis seen by chest radiograph and presence of symptoms associated with them
3.Pregnant or lactation women, or women with suspected pregnancy
4.Symptomatic CNS metastasis
5.Infection which needs treatment
6.Poorly controlled pleural effusion or peritoneal effusion
7.Patients judged by the investigator to be unfit for the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Sasaki |
Organization
National Hospital Organization Kanmon Medical Center
Division name
Medical Oncology
Zip code
Address
1-1 Chofusotoura-cho, Shimonoseki, Yamaguchi
TEL
083-241-1199
sasakih@kanmon-mc2.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Tamura |
Organization
Kyushu Breast Cancer Study Group
Division name
Executive Office
Zip code
Address
1-8-17-204, Watanabe-dori, Chuo-ku, Fukuoka
TEL
092-406-4166
Homepage URL
npo@chotsg.com
Sponsor or person
Institute
Kyushu Breast Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Non profit organization Clinical Hematology/ Oncology Treatment Study Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
北九州市立医療センター、社会保険久留米第一病院、福岡大学病院、九州がんセンター（福岡県）、熊本市民病院、熊本赤十字病院（熊本県）、大分県立病院（大分県）、関門医療センター（山口県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
http://www.chotsg.com
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
| 2011 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2016 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008776
| 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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