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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004839
Receipt No. R000005764
Scientific Title A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
Date of disclosure of the study information 2011/01/07
Last modified on 2018/07/13

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Basic information
Public title A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
Acronym A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
Scientific Title A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
Scientific Title:Acronym A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
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 effectiveness and safety of vinorelbine plus Gemcitabine combination therapy in patients with taxans refractory advanced or metastatic Breast Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival,
Overall survival,
Time to treatment failure,
Safety profiles

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 vinorelbine 25mg/m2,IV, Day1,8
Gemcitabine 1200mg/m2,IV,Day1,8
Every21 days
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)Patient who confirmed histologically HER2 negative as Metastatic breast cancer
2)ECOG PS 0-1
3)Mesurable disease as per RECIST criteria
4)Patients who have been taxans refractory and don't have recieved vinorelbine and Gemcitabine
5)Adequate organ functions confirmed with following major examination conducted within 14 days before each patient's registration
leukocyte>=3000mm3 or neutrophil>=1500mm3
hemoglobin>=9.0g/dL
platelet count>=100,000/mm3
AST,ALT<=100IU/L
total bilirubin=<1.5mg/dL
serum creatinine<=1.5mg/dL
6)Expected survival time : more than 3 months
7)Clinically no problem with an electrocardiogram
8) Given written informed concent
Key exclusion criteria 1) Pulmonary fibrosis or pneumonia
2) body cavity fluid whichi needs to be treated
3)Symptomatic brain metastasis
4) Active double cancer
5) The diabetes that is impossible of control and high blood pressure case
6)HBs antigen positive
7)Heart diseases with the following items
History of myocardial infarction ,unstable angina,post status of PTCA or CABG occurred within past 6 months
Congestive heart failure
Arrhythmia which needed to be treated
8)Apparently/possibly during pregnancy or lactation expectant
9) Serious drug allergy
10) Judged by the investigator to be unfit to be enrolled into the study
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Nishida
Organization Nissay Hospital
Division name Department of Breast Surgery
Zip code
Address 6-3-8,tachiuribori,nishi-ku,Osaka
TEL 06-6543-3581
Email nishida.yukihiro@nissay-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norikazu Masuda
Organization Kinki Multidisciplinary Breast Oncology Group
Division name Executive office
Zip code
Address 2-1-14,hoenzaka,chuo-ku,Osaka
TEL 06-6942-1331
Homepage URL
Email nmasuda@alpha.ocn.ne.jp

Sponsor
Institute Kinki Multidisciplinary Breast Oncology Group
Institute
Department

Funding Source
Organization Sakai Clinical Research Supporting Center(SCRSC)
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

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 07 Day
Last modified on
2018 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005764

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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