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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000447
Receipt No. R000000520
Scientific Title A Phase I/II Study of Vinorelbine plus Trastuzumab in Patients with Advanced/Recurrent Breast Cancer Previously Treated with Anthracyclines and Taxanes
Date of disclosure of the study information 2006/07/13
Last modified on 2010/08/04

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Basic information
Public title A Phase I/II Study of Vinorelbine plus Trastuzumab in Patients with Advanced/Recurrent Breast Cancer Previously Treated with Anthracyclines and Taxanes
Acronym A Phase I/II Study of Vinorelbine plus Trastuzumab
Scientific Title A Phase I/II Study of Vinorelbine plus Trastuzumab in Patients with Advanced/Recurrent Breast Cancer Previously Treated with Anthracyclines and Taxanes
Scientific Title:Acronym A Phase I/II Study of Vinorelbine plus Trastuzumab
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 This study is designed to assess the safety and efficacy of vinorelbine in combination with trastuzumab in patients with advanced/recurrent breast cancer and evidence of HER2 overexpression who have been previously treated with anthracyclines and taxanes (including pre- and postoperative adjuvant chemotherapy).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Feasibility and response rate
Key secondary outcomes Progression free survival, overall survival and adverse events are assessed

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 25 mg/m2 day 1, 8
Trastuzumab at 4 mg/kg for the first dosing and 2 mg/kg days 1, 8 ,15
Continue this regimen every 3 wks after safty profiles and tumor response are acceptable.
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.Advanced/recurrent breast cancer previously treated with anthracyclines and taxanes
2.Her2 positive
3.Mesasuarable or evaluable lesions suitable to RECIST
4.Advanced/recurrent breast cancer who were previously treated with taxanes and no other chemotherapeutic agents (oral fluorinated pyrimidines including capecitabine and TS-1)
5.Expected survival time: more than 3 months
6.Women aged 20 to 75 years at the time of enrollment
7.Performance Status 0-2
8.Adequate functions of major organs
9.Written informed consent
Key exclusion criteria 1.Significant interstitial pneumonia or pulmonary fibrosis by X-ray or CT scan
2.Acute myocardial infarction within 12 months before enrollment
3.Serious cardiac disease which is not controllable by drugs
4.Drug allergy
5.Uncontrolled diabetes or hypertension
6.Persistent use of systemic steroids
7.Uncontrolled medical complications
8.Metastasis to the central nervous system
9.Woman who are apparently or possibly pregnant or have desire to be come
pregnant
10.Double cancer
11.Infection or possible infection associated with clinical symptoms such as fever
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoshu Mitsuyama
Organization Kitakyushu Municipal Medical Center
Division name Surgery
Zip code
Address 1-1, 2-chome, Bashaku, Kokurakita-ku, Kitakyushu
TEL
Email

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
TEL
Homepage URL http://www.chotsg.com
Email

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization Non-profit Organization Clinical Hematology/Oncology Study Group
Organization
Division
Category of Funding Organization Self funding
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
2006 Year 07 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially 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
2006 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2010 Year 05 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
2006 Year 07 Month 13 Day
Last modified on
2010 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000520

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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