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Recruitment status Terminated
Unique ID issued by UMIN UMIN000008848
Receipt No. R000005165
Scientific Title Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Date of disclosure of the study information 2012/09/04
Last modified on 2019/03/12

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Basic information
Public title Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Acronym Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cance
Scientific Title Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Scientific Title:Acronym Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cance
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate maximum tolerated dose to determine recommended dose of gemcitabine and weekly paclitaxel in Her2 negative Recurrent breast cancer patients. In the next phase, we evaluate the safety and efficacy with recommended dose for these patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine maximum tolerated dose and recommended dose
Key secondary outcomes adverse events
time to progression

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 The optimal dosage of gemcitabine plus paclitaxel is decided by the dose limiting toxicity
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
75 years-old >
Gender Female
Key inclusion criteria 1.histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer
2.HER2 negative
3.over 20 years old, under 75 years old
4.ECOG performance status--0 or 1
5.All Pts are
1:after receiving anthracycline containing regimen for neoadjuvant and adjuvant setting, but no prior chemotherapy for metastatic disease including taxanes must have been completed more than 12 months before registering in this study
2:after receiving one regimen for locally advanced breast cancer including taxanes must have been completed more than 12 months before registering in this study
6.Patients who have passed the following periods from previous treatment
1:immunotherapy/endocrinetherapy
14 days from the final administration,
in case of LH-RH analogue, 28 days are
needed
2:chemotherapy 28 days
3:radiation therapy 28 days
4:operation 7 days
Key exclusion criteria *Her2 positive
*Prior administration of gemcitabine
*Pulmonary fibrosis or pneumonitis
*Abnormal cardiac function, myocardial infarction within 6 months
*Body cavity fluid which needs to treatment
*Active infection
*Severe complicated situation
*Severe drug allergic reaction
*Serious psychiatric illness
*After bone marrow transplantation
*After stem cell transplantation
*Symptomatic systemic brain metastasis
*Active double cancer
*Double chemotherapy
*Pregnancy, breast feeding, suspected pregnancy
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Murakami
Organization Hiroshima City Asa Hospital
Division name Breast Surgery
Zip code
Address 2-1-1 Kabeminami Asakita-ku Hiroshima
TEL 0828155211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Murakami
Organization Hiroshima Breast Cancer Study Group
Division name Hiroshima Cancer Support
Zip code
Address 1-20, Honkawa-cho, Naka-ku, Hiroshima
TEL 0825443770
Homepage URL http://www.hiroshima-cs.jp/
Email shigeru126@gmail.com

Sponsor
Institute Hiroshima Breast Cancer Study Group
Institute
Department

Funding Source
Organization Hiroshima Breast Cancer Study Group
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
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 Hiroshima Breast Cancer Study Group(広島県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 04 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
2010 Year 07 Month 15 Day
Date of IRB
2010 Year 09 Month 30 Day
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2012 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 09 Month 04 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005165

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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