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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007445
Receipt No. 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

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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
Email 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
Email npo@chotsg.com

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008776

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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