UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000447 |
|---|---|
| Receipt number | 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 15:18:39 |
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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
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
Sponsor or person
Institute
Kyushu Breast Cancer Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000520
